Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to confirm cardiac-based seizure detection in Cyberonics Model 106 VNS Therapy System.
Prospective, observational, unblinded, multi-site study designed to collect data on patients implanted with a Model 106 VNS Therapy System from baseline through an EMU stay of up to 5 days. After the EMU stay, patients will continue follow-up for safety for approximately two years or until final regulatory approval of the product.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Model 106 VNS Therapy System | Other | Model 106 VNS Therapy System includes a new Seizure Detection Algorithm (SDA) and corresponding Automatic Magnet Mode (AMM) feature. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Model 106 VNS Therapy System | Device | The VNS Therapy System is an adjunctive therapy for the treatment of epilepsy. VNS Therapy is available as a scheduled stimulation, this is cyclic stimulation between programmable On- and Off- times (e.g., a 30-second burst every 5 minutes). VNS Therapy is also available as on-demand stimulation, that is, when a magnet is introduced briefly over the implanted device (Magnet Mode). The AspireSR VNS Therapy System includes a new feature, Automatic Magnet Mode or AutoStim. In addition to Normal Mode and Magnet Mode, AspireSR uses a Seizure Detection Algorithm to identify a potential seizure onset based on associated heart rate increases known as ictal tachycardia. The purpose is to deliver stimulation at or near the onset of a seizure. |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Seizures Reported by Investigators and Triple Review | Subjects were admitted to the EMU and underwent standard continuous data collection of vEEG and ECG for 3 to 5 days. If a seizure occurred during the EMU stay, clinical investigators annotated the start and stop times, the type of seizure, the presumed seizure onset location, and the lobe of origin as applicable. Following the EMU data collection phase of the trial, the de-identified, continuous electronic records (per patient) from the EMU period were provided to an independent and blinded triple review panel. This panel evaluated the EEG data and annotated seizure onset, seizure offset, and a description of seizure type. In the absence of video, seizure types could only be specified as: partial (particular type not denoted), generalized (non-absence), absence, or partial with secondary generalization. | Epilepsy Monitoring Unit Stay |
| Observed Sensitivity Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting | Sensitivity is the total number of seizures detected divided by the total number of seizures during EMU stay.Data used to support sensitivity analyses included digital ECG/EEG files,corresponding M106 device downloads,and CRF data.Seizure and non-seizure EEG segments were provided to independent reviewers to confirm seizure occurrence and define EEG seizure onset times.Seizure onset times were then compared with observed M106 device detections at the detection threshold setting for AutoStim that the patient was randomized to(SDA 2;60%,SDA 4;40%,SDA 6;20%).Sensitivity is only reported if the heart rate surpassed the programmed detection threshold.Number of participants is total number of subjects who had seizures during the EMU stay. An "Ictal tachycardia Seizure" is a seizure with Ictal Heart rate >= 100 bpm & at least 55% increase, or 35 bpm increase from baseline) Bootstrap confidence intervals using 3000 bootstrap samples. n=total number of seizures; N= number of participants | Epilepsy Monitoring Unit (EMU) Stay |
| Modeled Sensitivity Based on Heart Rate Increase Associated With Seizures by SDA Setting Post-Processed Through Bench-top Device Simulant | Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay. Data used to support sensitivity analyses included digital ECG/EEG files, corresponding M106 device downloads, and CRF data. Seizure onset times were compared with modeled M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. The participants' surface ECG data collected during the trial and passed through DMSDAT, a validated bench-top simulant of the Automatic Stimulation feature, was used to produce modeled results for each threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). Number of participants is total number of subjects who experienced seizures during the EMU stay. Bootstrap confidence intervals using 3000 bootstrap samples. |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of Cardiac R-Wave Detection | Cardiac R-wave detection was evaluated against concurrent ECG data (i.e. detailed R-wave test) collected during implant, the first titration visit, at the beginning of the EMU stay, and at the 12 month visit. R-R intervals were calculated using detected R-waves from the Implantable Pulse Generator (IPG) and from a standard ECG monitor during a pre-specified time interval. A time series 10 seconds was recorded using the IPG SyncPulse feature. Simultaneously, a corresponding time series over the same interval was recorded using a standard ECG monitor. The total number of beats accurately detected in the entire study population is reported. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bryan Olin | Cyberonics, Inc. | Study Director |
| Paul Boon | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Erasme | Anderlecht | Belgium | ||||
| Cliniques Universitaires Saint-Luc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26552564 | Result | Boon P, Vonck K, van Rijckevorsel K, El Tahry R, Elger CE, Mullatti N, Schulze-Bonhage A, Wagner L, Diehl B, Hamer H, Reuber M, Kostov H, Legros B, Noachtar S, Weber YG, Coenen VA, Rooijakkers H, Schijns OE, Selway R, Van Roost D, Eggleston KS, Van Grunderbeek W, Jayewardene AK, McGuire RM. A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation. Seizure. 2015 Nov;32:52-61. doi: 10.1016/j.seizure.2015.08.011. Epub 2015 Sep 21. | |
| 27450311 |
Not provided
Not provided
A total of 35 subjects were screened; (4) did not meet study criteria, (31) were treated/implanted with the AspireSR® VNS Therapy® System, of which (1) was implanted with version 1 of the AspireSR® VNS Therapy® System and (30) were implanted with version 2 (= ITT population).
Eligible subjects were at least 18 years old, with a clinical diagnosis of medically refractory epilepsy dominated by partial seizures suitable for implantation with the Model 106 VNS Therapy System and a history of ictal tachycardia, defined as heart rate above 100 bpm during a seizure and at least a 55% increase or 35 bpm increase from baseline.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled and Treated Population (Safety Population) | Consists of all patients who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2. The safety population will be used for all safety analyses. (N=31 subjects). In version 2 of the AspireSR VNS Therapy System, the TVS diodes (present in version 1) were removed from the electrical circuit to address the accumulation of electrical charge on the sensing node (e.g. generator-can) following delivery of a stimulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | VNS Therapy (Safety Population) | The safety population consists of all patients who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summary of Seizures Reported by Investigators and Triple Review | Subjects were admitted to the EMU and underwent standard continuous data collection of vEEG and ECG for 3 to 5 days. If a seizure occurred during the EMU stay, clinical investigators annotated the start and stop times, the type of seizure, the presumed seizure onset location, and the lobe of origin as applicable. Following the EMU data collection phase of the trial, the de-identified, continuous electronic records (per patient) from the EMU period were provided to an independent and blinded triple review panel. This panel evaluated the EEG data and annotated seizure onset, seizure offset, and a description of seizure type. In the absence of video, seizure types could only be specified as: partial (particular type not denoted), generalized (non-absence), absence, or partial with secondary generalization. | ITT Population: consists of all patients implanted with the AspireSR VNS Therapy System version 2 and who have any EMU record. | Posted | Number | Seizures | Epilepsy Monitoring Unit Stay |
|
From baseline up to 24 Months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VNS Therapy - Safety Population | All adverse events were collected from baseline up to the 24-month follow-up visit for all subjects treated/implanted with the AspireSR® VNS Therapy® system. All SAEs are reported in the SAE data table, whereas only the most common AEs (> 5%) are reported in the AE data table. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wim Van Grunderbeek, Clinical Operations Manager Cyberonics Europe | Cyberonics Europe BVBA | +32 2 720 95 93 | 312 | wim.vangrunderbeek@cyberonics.com |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Epilepsy Monitoring Unit (EMU) Stay |
| Potential False Positives Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting | Potential false positive rate is defined as the sum across all patients of the total number of potential false positive detections divided by the sum across all patients of the appropriate monitoring time during the EMU stay. Data used to support the potential false positive rate analyses included digital ECG/EEG files retrieved from the EMU evaluation, corresponding M106 device downloads, and triple review results of EEG recordings. The evaluated EMU monitoring time includes a daily 3 minutes stepping exercise during which patients stepped up and down on a step stool at a submaximal effort leve. | Epilepsy Monitoring Unit (EMU) Stay |
| At Implant, First Titration Visit, Day 1 EMU and 12 Months |
| Characterization of Latency Period: Analysis of Observed Latency for True Positive Detections by Randomized SDA Setting | Latency is defined as the time difference between SDA detection time and the annotated seizure onset time. The earliest SDA detection was considered for each seizure. Seizure onset times were compared with M106 device detections at the randomized SDA setting. Negative latencies indicate that the SDA detection preceded the seizure onset time. The median latency is presented for seizures which met the definition of ictal tachycardia as well as all seizure types and indicate the observed latency range. | Epilepsy Monitoring Unit (EMU) Stay |
| Human Factors and Usability of the AspireSR® VNS Therapy® System. | Usability survey data were collected from all site personnel who used the handheld programmer to evaluate the usability of the AspireSR® VNS Therapy® System.The device usability survey contained 17 questions that measure usability on a five-point Likert scale ranging from "Extremely Difficult" (5) to "Extremely Easy" (1). Site personnel were asked to assess usability of the software features, instructions for use, training materials, and overall usability of the system at four different time points. The time points include implant/recovery and the end of EMU. Usability was calculated as percentage of the users who found the usability of system to be "easy-2" or extremely easy-1". | At implant/recovery up to EMU Discharge (2 to 4 weeks) |
| Changes From Baseline in Seizure Frequency | Seizure frequency was calculated at 3, 6, 12, 18 and 24 month follow-up visits based on seizure diary information and compared to baseline estimates. Response rate was computed and summarized for partial seizures (SPS, CPS and CPS with 2nd GTCs) and overall seizure types as the percentage of patients that achieved ≥50% seizure reduction per month from baseline by visit. | Up to 24 Month visit |
| Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3) | Investigators completed the National Hospital Seizure Severity Scale (NHS3) questionnaire at screening, at the end of the EMU stay (provided a seizure occurred during the EMU stay), and at follow-up visits. Severity was evaluated by seizure type. The range of NHS3 scale is 1-27 with 1 being the least severe and 27 being the most severe. Negative median value means improvement. | up to 24 Months Visit |
| Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Seizure Severity Questionnaire (SSQ) | Clinical outcomes such as seizure severity, intensity and post-ictal duration were also assessed during the long-term follow-up visits (3, 6, 12, 18 and 24 months) with patient reported questionnaires (SSQ; Seizure Severity Questionnaire). The range for SSQ (all sub-scores) is 1-7 with 1 being the least severe and 7 being the most severe. Mean SSQ scores at 3, 6, 12, 18 and 24 months were compared to baseline. A change from baseline is calculated as baseline minus follow-up visit score to correspond to the Minimally Important Change (MIC) criteria as defined in the Scoring Scheme for SSQ v2. Questionnaire. Subscale scores were averaged to compute the SSQ Total Score | Up to 24 Month visit |
| Proportion of Seizures Ending During Stimulation by Type | Clinical outcomes including seizure duration and cessation were assessed with vEEG during EMU stay. Number of seizures treated with Automatic Stimulation during EMU were evaluated. Of these seizures, those ending during the 60 second course of Automatic Stimulation were assessed and tabulated by seizure type. | Epilepsy Monitoring Unit (EMU) Stay |
| Summary of Seizure Duration (Seconds) for All Seizure Types by Subgroup(ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated) | Seizure duration was calculated using historical EEG data from patients enrolled in the trial and compared to the duration of seizures that occurred during the study EMU stay. The seizure start and end times were determined via clinical observation and/or through an adjudication process with qualified EEG reviewers. | Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay |
| Summary of Post Ictal Duration (Seconds) for All Seizure Types (ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated) | Post-ictal duration was quantified by identifying the time at which the number of EEG channels within the 95% confidence interval of relative power reaches a number that is consistent with that during the pre-seizure period. This measure represents the amount of time required following a seizure until the EEG recovers to the pre-seizure state. It is used to objectively estimate patient recovery time. Historical seizures were baseline EEG recordings measured during monitoring prior to implantation. Post-ictal duration is only reported for seizures with Post Ictal Duration (seconds) annotated and >= 20% Heart Rate Rise | Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay |
| Changes in Quality of Life on Patient Reported Questionnaire (QOLIE-31-P) | Quality of life data was collected using patient-completed QOLIE-31-P surveys and compared between baseline and follow-up visits. The MIC score for each subscale defines the threshold for Minimally Important Change. If a score exceeds the MIC Score, the improvement from baseline is considered clinically significant. The range for QOLIE-31-P (all sub-scores) is 0-100 with higher scores reflecting greater well-being.Subscale scores were averaged to compute the QOLIE Total Score. | up to 24 Months Visit |
| Overall Summary of Seizure Intensity by Subgroup | Quantitative evaluation of EEG was used to characterize the seizures that were treated with Automatic Stimulation. Intensity was evaluated by surveying the average power level from the 10-20 system EEG channel of maximum output during the course of the seizure. Intensity was only reported for seizures with intensity annotated and >= 20% Heart Rate Rise. The relative intensity was calculated by normalizing the power calculations to the pre-seizure state, and thus the reported changes are dimensionless. n= number of seizures | Historical Seizures and Seizures during Epilepsy Monitoing Unit Stay |
| Post-stimulation Heart Rate Changes | During a 1 hour period during the EMU stay, the VNS Therapy device was programmed to normal mode stimulation ON time 30 seconds, OFF time 5 minutes. AutoStim and Magnet Mode were programmed OFF. In this hour, 10 to 11 normal mode stimulations can be expected. Around each of these stimulations, ECG data were collected to assess potential stimulation related heart rate changes (during stimulation, after stimulation and after black-out time). A black-out time is a period after stimulation during which no seizure detections can occur, to ensure that potential stimulation related heart rate changes were not seen as ictal tachycardia that would trigger false positive detection. During the trial, the black-out time was programmed to 30 seconds. The heart rate changes for all stimulations and all patients were averaged. | EMU stay |
| Brussels |
| Belgium |
| Universitair Ziekenhuis Gent | Ghent | Belgium |
| Epilepsie-Zentrum Bethel | Bielefeld | Germany |
| Universitätsklinikum Bonn | Bonn | Germany |
| Universitätsklinikum Erlangen | Erlangen | Germany |
| Albert-Ludwigs-Universität | Freiburg im Breisgau | Germany |
| Ludwig-Maximilians-Universität München | Munich | Germany |
| Universitätsklinikum Tübingen | Tübingen | Germany |
| Kempenhaege | Heeze | Netherlands |
| Oslo University Hospital | Oslo | Norway |
| King's College Hospital | London | United Kingdom |
| The National Hospital for Neurology and Neurosurgery | London | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | United Kingdom |
| Derived |
| Verrier RL, Nearing BD, Olin B, Boon P, Schachter SC. Baseline elevation and reduction in cardiac electrical instability assessed by quantitative T-wave alternans in patients with drug-resistant epilepsy treated with vagus nerve stimulation in the AspireSR E-36 trial. Epilepsy Behav. 2016 Sep;62:85-9. doi: 10.1016/j.yebeh.2016.06.016. Epub 2016 Jul 21. |
| years |
|
| Age, Customized | Median | Full Range | years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Cognitive Status | Number | participants |
|
| Age at Epilepsy Onset | Median | Full Range | years |
|
| Age at Epilepsy Onset | Mean | Standard Deviation | years |
|
| Previous Brain or Epilepsy Surgery | Number | participants |
|
| Etiology | Number | participants |
|
| Family History of Seizures | Number | participants |
|
| Seizures with Auras in the Past 2 Months | Number | participants |
|
| OG000 |
| Reported by Investigators |
All seizures that occurred during EMU stay and that were identified by investigators. |
| OG001 | Reported by Triple Review | All seizures that occurred during EMU stay and that were identified by triple review post EMU. |
| OG002 | Total | Seizures from an ITT subject that were either identified by the investigator during EMU evaluation or during the triple review process of EEG data. |
|
|
| Primary | Observed Sensitivity Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting | Sensitivity is the total number of seizures detected divided by the total number of seizures during EMU stay.Data used to support sensitivity analyses included digital ECG/EEG files,corresponding M106 device downloads,and CRF data.Seizure and non-seizure EEG segments were provided to independent reviewers to confirm seizure occurrence and define EEG seizure onset times.Seizure onset times were then compared with observed M106 device detections at the detection threshold setting for AutoStim that the patient was randomized to(SDA 2;60%,SDA 4;40%,SDA 6;20%).Sensitivity is only reported if the heart rate surpassed the programmed detection threshold.Number of participants is total number of subjects who had seizures during the EMU stay. An "Ictal tachycardia Seizure" is a seizure with Ictal Heart rate >= 100 bpm & at least 55% increase, or 35 bpm increase from baseline) Bootstrap confidence intervals using 3000 bootstrap samples. n=total number of seizures; N= number of participants | Patients from the ITT population who completed the EMU evaluation and that had at least one reported seizure during the EMU evaluation that was confirmed by triple review; (Investigator Reported Seizures + Triple Review). | Posted | Mean | 95% Confidence Interval | percentage of True Positive Detections | Epilepsy Monitoring Unit (EMU) Stay |
|
|
|
| Primary | Modeled Sensitivity Based on Heart Rate Increase Associated With Seizures by SDA Setting Post-Processed Through Bench-top Device Simulant | Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay. Data used to support sensitivity analyses included digital ECG/EEG files, corresponding M106 device downloads, and CRF data. Seizure onset times were compared with modeled M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. The participants' surface ECG data collected during the trial and passed through DMSDAT, a validated bench-top simulant of the Automatic Stimulation feature, was used to produce modeled results for each threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). Number of participants is total number of subjects who experienced seizures during the EMU stay. Bootstrap confidence intervals using 3000 bootstrap samples. | Patients from the ITT population who completed the EMU evaluation and that had at least one reported seizure during the EMU evaluation that was confirmed by triple review; (Investigator Reported Seizures + Triple Review). | Posted | Mean | 95% Confidence Interval | percentage of True Positive Detections | Epilepsy Monitoring Unit (EMU) Stay |
|
|
|
| Primary | Potential False Positives Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting | Potential false positive rate is defined as the sum across all patients of the total number of potential false positive detections divided by the sum across all patients of the appropriate monitoring time during the EMU stay. Data used to support the potential false positive rate analyses included digital ECG/EEG files retrieved from the EMU evaluation, corresponding M106 device downloads, and triple review results of EEG recordings. The evaluated EMU monitoring time includes a daily 3 minutes stepping exercise during which patients stepped up and down on a step stool at a submaximal effort leve. | ITT Population: all patients implanted with Model 106 VNS Therapy System Version 2 and who have any EMU record. 10 participants analyzed for >=60% setting, 12 participants analyzed for >=40% setting, 8 participants analyzed for >=20% setting. | Posted | Number | 95% Confidence Interval | Potential False Positive per Hour | Epilepsy Monitoring Unit (EMU) Stay |
|
|
|
| Secondary | Validation of Cardiac R-Wave Detection | Cardiac R-wave detection was evaluated against concurrent ECG data (i.e. detailed R-wave test) collected during implant, the first titration visit, at the beginning of the EMU stay, and at the 12 month visit. R-R intervals were calculated using detected R-waves from the Implantable Pulse Generator (IPG) and from a standard ECG monitor during a pre-specified time interval. A time series 10 seconds was recorded using the IPG SyncPulse feature. Simultaneously, a corresponding time series over the same interval was recorded using a standard ECG monitor. The total number of beats accurately detected in the entire study population is reported. | ITT population | Posted | Number | percentage of beats accurately detected | At Implant, First Titration Visit, Day 1 EMU and 12 Months |
|
|
|
| Secondary | Characterization of Latency Period: Analysis of Observed Latency for True Positive Detections by Randomized SDA Setting | Latency is defined as the time difference between SDA detection time and the annotated seizure onset time. The earliest SDA detection was considered for each seizure. Seizure onset times were compared with M106 device detections at the randomized SDA setting. Negative latencies indicate that the SDA detection preceded the seizure onset time. The median latency is presented for seizures which met the definition of ictal tachycardia as well as all seizure types and indicate the observed latency range. | ITT Population n=total number of seizures in each category | Posted | Median | Full Range | seconds | Epilepsy Monitoring Unit (EMU) Stay |
|
|
|
| Secondary | Human Factors and Usability of the AspireSR® VNS Therapy® System. | Usability survey data were collected from all site personnel who used the handheld programmer to evaluate the usability of the AspireSR® VNS Therapy® System.The device usability survey contained 17 questions that measure usability on a five-point Likert scale ranging from "Extremely Difficult" (5) to "Extremely Easy" (1). Site personnel were asked to assess usability of the software features, instructions for use, training materials, and overall usability of the system at four different time points. The time points include implant/recovery and the end of EMU. Usability was calculated as percentage of the users who found the usability of system to be "easy-2" or extremely easy-1". | ITT Population | Posted | Number | Percentage of participants rated 1 or 2 | At implant/recovery up to EMU Discharge (2 to 4 weeks) |
|
|
|
| Secondary | Changes From Baseline in Seizure Frequency | Seizure frequency was calculated at 3, 6, 12, 18 and 24 month follow-up visits based on seizure diary information and compared to baseline estimates. Response rate was computed and summarized for partial seizures (SPS, CPS and CPS with 2nd GTCs) and overall seizure types as the percentage of patients that achieved ≥50% seizure reduction per month from baseline by visit. | ITT population | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 24 Month visit |
|
|
|
| Secondary | Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3) | Investigators completed the National Hospital Seizure Severity Scale (NHS3) questionnaire at screening, at the end of the EMU stay (provided a seizure occurred during the EMU stay), and at follow-up visits. Severity was evaluated by seizure type. The range of NHS3 scale is 1-27 with 1 being the least severe and 27 being the most severe. Negative median value means improvement. | ITT Population | Posted | Median | Full Range | Units on a scale | up to 24 Months Visit |
|
|
|
|
| Secondary | Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Seizure Severity Questionnaire (SSQ) | Clinical outcomes such as seizure severity, intensity and post-ictal duration were also assessed during the long-term follow-up visits (3, 6, 12, 18 and 24 months) with patient reported questionnaires (SSQ; Seizure Severity Questionnaire). The range for SSQ (all sub-scores) is 1-7 with 1 being the least severe and 7 being the most severe. Mean SSQ scores at 3, 6, 12, 18 and 24 months were compared to baseline. A change from baseline is calculated as baseline minus follow-up visit score to correspond to the Minimally Important Change (MIC) criteria as defined in the Scoring Scheme for SSQ v2. Questionnaire. Subscale scores were averaged to compute the SSQ Total Score | ITT Population | Posted | Mean | Standard Deviation | Units on a scale | Up to 24 Month visit |
|
|
|
|
| Secondary | Proportion of Seizures Ending During Stimulation by Type | Clinical outcomes including seizure duration and cessation were assessed with vEEG during EMU stay. Number of seizures treated with Automatic Stimulation during EMU were evaluated. Of these seizures, those ending during the 60 second course of Automatic Stimulation were assessed and tabulated by seizure type. | ITT Population; All Treated Seizures n=total number of seizures | Posted | Number | Percentage of Seizures Ending | Epilepsy Monitoring Unit (EMU) Stay |
|
|
|
| Secondary | Summary of Seizure Duration (Seconds) for All Seizure Types by Subgroup(ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated) | Seizure duration was calculated using historical EEG data from patients enrolled in the trial and compared to the duration of seizures that occurred during the study EMU stay. The seizure start and end times were determined via clinical observation and/or through an adjudication process with qualified EEG reviewers. | Patients from the ITT population who had at least one seizure during the EMU stay and who had at least one historical seizure recorded (and duration was annotated). n=total number of seizures | Posted | Mean | Standard Deviation | Seconds | Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay |
|
|
|
| Secondary | Summary of Post Ictal Duration (Seconds) for All Seizure Types (ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated) | Post-ictal duration was quantified by identifying the time at which the number of EEG channels within the 95% confidence interval of relative power reaches a number that is consistent with that during the pre-seizure period. This measure represents the amount of time required following a seizure until the EEG recovers to the pre-seizure state. It is used to objectively estimate patient recovery time. Historical seizures were baseline EEG recordings measured during monitoring prior to implantation. Post-ictal duration is only reported for seizures with Post Ictal Duration (seconds) annotated and >= 20% Heart Rate Rise | Patients from the ITT population who had at least one seizure during the EMU stay and who had at least one historical seizure recorded (and duration was annotated). n=total number of seizures | Posted | Mean | Standard Deviation | Seconds | Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay |
|
|
|
| Secondary | Changes in Quality of Life on Patient Reported Questionnaire (QOLIE-31-P) | Quality of life data was collected using patient-completed QOLIE-31-P surveys and compared between baseline and follow-up visits. The MIC score for each subscale defines the threshold for Minimally Important Change. If a score exceeds the MIC Score, the improvement from baseline is considered clinically significant. The range for QOLIE-31-P (all sub-scores) is 0-100 with higher scores reflecting greater well-being.Subscale scores were averaged to compute the QOLIE Total Score. | ITT Population | Posted | Mean | Standard Deviation | units on a scale | up to 24 Months Visit |
|
|
|
|
| Secondary | Overall Summary of Seizure Intensity by Subgroup | Quantitative evaluation of EEG was used to characterize the seizures that were treated with Automatic Stimulation. Intensity was evaluated by surveying the average power level from the 10-20 system EEG channel of maximum output during the course of the seizure. Intensity was only reported for seizures with intensity annotated and >= 20% Heart Rate Rise. The relative intensity was calculated by normalizing the power calculations to the pre-seizure state, and thus the reported changes are dimensionless. n= number of seizures | Patients from the ITT population who had at least one seizure during EMU stay and who had at least one historical seizure recorded. n=total number of seizures | Posted | Mean | Standard Deviation | unitless | Historical Seizures and Seizures during Epilepsy Monitoing Unit Stay |
|
|
|
| Secondary | Post-stimulation Heart Rate Changes | During a 1 hour period during the EMU stay, the VNS Therapy device was programmed to normal mode stimulation ON time 30 seconds, OFF time 5 minutes. AutoStim and Magnet Mode were programmed OFF. In this hour, 10 to 11 normal mode stimulations can be expected. Around each of these stimulations, ECG data were collected to assess potential stimulation related heart rate changes (during stimulation, after stimulation and after black-out time). A black-out time is a period after stimulation during which no seizure detections can occur, to ensure that potential stimulation related heart rate changes were not seen as ictal tachycardia that would trigger false positive detection. During the trial, the black-out time was programmed to 30 seconds. The heart rate changes for all stimulations and all patients were averaged. | ITT population | Posted | Mean | Standard Deviation | percentage change | EMU stay |
|
|
|
| 10 |
| 31 |
| 26 |
| 31 |
| Hemorrhage Subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Aphonia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Status Epilepticus | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Incision Site Pain | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Tooth Abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Psychotic Disorder | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Dyspnea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Medical Device Pain | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
Not provided
| Ictal Tachycardia Seizures, SDA 6 (n=2; N=2) |
|
| >= 70% heart rate increase, SDA 4 (n=3; N=2) |
|
| >= 60% heart rate increase, SDA 2 (n=1; N=1) |
|
| >= 60% heart rate increase, SDA 4 (n=4; N=2) |
|
| >= 50% heart rate increase, SDA 4 (n=6; N=2) |
|
| >= 50% heart rate increase, SDA 6 (n=1; N=1) |
|
| >= 40% heart rate increase, SDA 4 (n=9; N=2)) |
|
| >= 40% heart rate increase, SDA 6 (n=4; N=3)) |
|
| >= 30% heart rate increase, SDA 6 (n=8; N=4)) |
|
| >= 20% heart rate increase, SDA 6 (n=12; N=5) |
|
|
| >= 40% heart rate increase at SDA 4 (n=19) |
|
| >= 30% heart rate increase at SDA 5 (n=36) |
|
| >= 20% heart rate increase at SDA 6 (n=53) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| 12 Month Follow-up (n=14) |
|
| SDA 6 (n=2,37) |
|
| Laminated Instruction Card (n=20, 21) |
|
| Interrogation (Short) (n=22, 24) |
|
| Interrogation (Long) (n=21, 24) |
|
| Change Parameters (n=22, 24) |
|
| Heartbeat Sensitivity Configuration (n=20, 24) |
|
| Seizure Detection Configuration (n=21, 23) |
|
| System Diagnostic (n=21,24) |
|
| View Database (n=17, 22) |
|
| View Seizure Detection Data (n=15, 22) |
|
| Export Data (n=7, 15) |
|
| Generator Battery Status Indicators (n=20, 24) |
|
| Handheld Battery Status Indicator (n=19, 24) |
|
| Warning Messages (n=13, 24) |
|
| Overall Usability (n=20, 24) |
|
| Follow-up 12 Month n=27,25 |
|
| Follow-up 18 Month n=26,24 |
|
| Follow-up 24 Month n=27,25 |
|
| Baseline to 3 Months; n=12,20,6,2 |
|
| Baseline to 6 Months; n=9,20,5,3 |
|
| Baseline to 12 Months; n=9,20,6,5 |
|
| Baseline to 18 Months; n=7,20,7,3 |
|
| Baseline to 24 Months; n=8,20,2,2 |
|
| Signed Rank Test |
Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero |
| 0.156 |
| 2-Sided |
| No |
| Superiority or Other |
| Baseline to 6 months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | >0.999 | 2-Sided | No | Superiority or Other |
| Baseline to 12 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.906 | 2-Sided | No | Superiority or Other |
| Baseline to 18 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.188 | 2-Sided | No | Superiority or Other |
| Baseline to 24 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.906 | 2-Sided | No | Superiority or Other |
| Baseline to EMU Discharge | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | <0.001 | 2-Sided | No | Superiority or Other |
| Baseline to 3 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.106 | 2-Sided | No | Superiority or Other |
| Baseline to 6 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.012 | 2-Sided | No | Superiority or Other |
| Baseline to 12 Months | s | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.008 | 2-Sided | No | Superiority or Other |
| Baseline to 18 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.009 | 2-Sided | No | Superiority or Other |
| Baseline to 24 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.029 | 2-Sided | No | Superiority or Other |
| Baseline to EMU Discharge | s | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.500 | 2-Sided | No | Superiority or Other |
| Baseline to 3 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | >0.999 | 2-Sided | No | Superiority or Other |
| Baseline to 6 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.500 | 2-Sided | No | Superiority or Other |
| Baseline to 12 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.500 | 2-Sided | No | Superiority or Other |
| Baseline to 18 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.188 | 2-Sided | No | Superiority or Other |
| Baseline to 24 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.500 | 2-Sided | No | Superiority or Other |
| Baseline to EMU Discharge | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.500 | 2-Sided | No | Superiority or Other |
| Baseline to 3 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | >0.999 | 2-Sided | No | Superiority or Other |
| Baseline to 6 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | >0.999 | 2-Sided | No | Superiority or Other |
| Baseline to 12 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.125 | 2-Sided | No | Superiority or Other |
| Baseline to 18 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.500 | 2-Sided | No | Superiority or Other |
| Baseline to 24 Months | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero | 0.500 | 2-Sided | No | Superiority or Other |
| Activity During Seizure; n=26,28,27,25,22 MIC=0.50 |
|
| Overall Recovery; n=25,29,27,27,26 MIC=0.39 |
|
| Overall Severity; n=27,30,29,28,27 MIC=0.48 |
|
| Postictal Emotional Rec. n=26,29,28,27,26 MIC=0.42 |
|
| Postictal Physical Reco; n=27,30,28,28,27 MIC=0.34 |
|
| Postictal Cognitive Rec.;n=28,30,29,28,27 MIC=0.48 |
|
| Signed Rank Test |
Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. |
| 0.0942 |
| 2-Sided |
| No |
| Superiority or Other |
| Overall Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.2831 | 2-Sided | No | Superiority or Other |
| Overall Severity Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.3639 | 2-Sided | No | Superiority or Other |
| Postictal Emotional Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.4470 | 2-Sided | No | Superiority or Other |
| Postictal Physical Recovery Score | s | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.1311 | 2-Sided | No | Superiority or Other |
| Postictal Cognitive Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.3898 | 2-Sided | No | Superiority or Other |
| SSQ Total Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0511 | 2-Sided | No | Superiority or Other |
| Activity During Seizures Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0019 | 2-Sided | No | Superiority or Other |
| Overall Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.1106 | 2-Sided | No | Superiority or Other |
| Overall Severity Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.1273 | 2-Sided | No | Superiority or Other |
| Postictal Emotional Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.1305 | 2-Sided | No | Superiority or Other |
| Postictal Physical Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.1123 | 2-Sided | No | Superiority or Other |
| Postictal Cognitive Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.2309 | 2-Sided | No | Superiority or Other |
| SSQ Total Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.3191 | 2-Sided | No | Superiority or Other |
| Activity During Seizures Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0679 | 2-Sided | No | Superiority or Other |
| Overall Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.2082 | 2-Sided | No | Superiority or Other |
| Overall Severity Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.1790 | 2-Sided | No | Superiority or Other |
| Postictal Emotional Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.6869 | 2-Sided | No | Superiority or Other |
| Postictal Physical Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.6094 | 2-Sided | No | Superiority or Other |
| Postictal Cognitive Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.1530 | 2-Sided | No | Superiority or Other |
| SSQ Total Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.3339 | 2-Sided | No | Superiority or Other |
| Activity During Seizures Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.1473 | 2-Sided | No | Superiority or Other |
| Overall Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.5035 | 2-Sided | No | Superiority or Other |
| Overall Severity Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.6653 | 2-Sided | No | Superiority or Other |
| Postictal Emotional Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.8622 | 2-Sided | No | Superiority or Other |
| Postictal Physical Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.4456 | 2-Sided | No | Superiority or Other |
| Postictal Cognitive Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.6876 | 2-Sided | No | Superiority or Other |
| SSQ Total Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0328 | 2-Sided | No | Superiority or Other |
| Activity During Seizures Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0067 | 2-Sided | No | Superiority or Other |
| Overall Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.5928 | 2-Sided | No | Superiority or Other |
| Overall Severity Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.7179 | 2-Sided | No | Superiority or Other |
| Postictal Emotional Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.5014 | 2-Sided | No | Superiority or Other |
| Postictal Physical Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.9640 | 2-Sided | No | Superiority or Other |
| Postictal Cognitive Recovery Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.8537 | 2-Sided | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Complex Partial Seizures (n=11) |
|
| Secondary Generalized Seizures (n=2) |
|
| Generalized Seizures (n=9) |
|
| Debilitating Seizures (CPS, SGS, GEN) (n=22) |
|
| Unknown Type (n=2) |
|
|
| CPS Secondary Generalized n=12,0,0 |
|
| Generalized Seizures n=0,6,0 |
|
| Debilitating Seizures n=72,12,7 |
|
|
| CPS Secondary Generalized n=5,0,0 |
|
| Generalized Seizures n=0,1,0 |
|
| Debilitating Seizures n=64,7,7 |
|
| Energy/Fatigue (MIC=5.25) n=28,29,28,28,25 |
|
| Emotional Well Being (MIC=4.76) n=28,29,28,28,26 |
|
| Social Functioning (MIC=3.95) n=27,28,26,27,26 |
|
| Cognitive functioning (MIC=5.34) n=28,29,28,27,26 |
|
| Medication Effects (MIC=5.00) n=28,29,28,26,26 |
|
| Seizure Worry (MIC=7.42) n=28,29,28,28,26 |
|
| Overall Quality of Life (MIC=6.42)n=28,29,28,28,26 |
|
| Signed Rank Test |
Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. |
| 0.6562 |
| 2-Sided |
| No |
| Superiority or Other |
| Emotional well being Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.9376 | 2-Sided | No | Superiority or Other |
| Social Functioning Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0100 | 2-Sided | No | Superiority or Other |
| Cognitive functioning Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.8532 | 2-Sided | No | Superiority or Other |
| Medication Effects Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.4954 | 2-Sided | No | Superiority or Other |
| Seizure Worry Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.1877 | 2-Sided | No | Superiority or Other |
| Overall Quality of Life Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.4189 | 2-Sided | No | Superiority or Other |
| QOLIE Overall Total Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.2365 | 2-Sided | No | Superiority or Other |
| Energy/Fatigue Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.4138 | 2-Sided | No | Superiority or Other |
| Emotional well being Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.8701 | 2-Sided | No | Superiority or Other |
| Social Functioning Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0527 | 2-Sided | No | Superiority or Other |
| Cognitive functioning Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.1353 | 2-Sided | No | Superiority or Other |
| Medication Effects Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.6927 | 2-Sided | No | Superiority or Other |
| Seizure Worry Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.4964 | 2-Sided | No | Superiority or Other |
| Overall Quality of Life Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0238 | 2-Sided | No | Superiority or Other |
| QOLIE Overall Total Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0139 | 2-Sided | No | Superiority or Other |
| Energy/Fatigue Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.2822 | 2-Sided | No | Superiority or Other |
| Emotional well being Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.1363 | 2-Sided | No | Superiority or Other |
| Social Functioning Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0019 | 2-Sided | No | Superiority or Other |
| Cognitive functioning Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.1293 | 2-Sided | No | Superiority or Other |
| Medication Effects Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.5252 | 2-Sided | No | Superiority or Other |
| Seizure Worry Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0642 | 2-Sided | No | Superiority or Other |
| Overall Quality of Life Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0025 | 2-Sided | No | Superiority or Other |
| QOLIE Overall Total Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0024 | 2-Sided | No | Superiority or Other |
| Energy/Fatigue Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.4464 | 2-Sided | No | Superiority or Other |
| Emotional well being Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0511 | 2-Sided | No | Superiority or Other |
| Social Functioning Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0002 | 2-Sided | No | Superiority or Other |
| Cognitive Functioning Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0296 | 2-Sided | No | Superiority or Other |
| Medication Effects Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.3115 | 2-Sided | No | Superiority or Other |
| Seizure Worry Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0270 | 2-Sided | No | Superiority or Other |
| Overall Quality of Life Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0008 | 2-Sided | No | Superiority or Other |
| QOLIE Overall Total Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0683 | 2-Sided | No | Superiority or Other |
| Energy/Fatigue Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.2226 | 2-Sided | No | Superiority or Other |
| Emotional well being Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0823 | 2-Sided | No | Superiority or Other |
| Social Functioning Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.1459 | 2-Sided | No | Superiority or Other |
| Cognitive Functioning Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.2610 | 2-Sided | No | Superiority or Other |
| Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.9119 | 2-Sided | No | Superiority or Other |
| Seizure Worry Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0826 | 2-Sided | No | Superiority or Other |
| Overall Quality of Life Final Score | Signed Rank Test | Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero. | 0.0036 | 2-Sided | No | Superiority or Other |
| Complex Partial Seizures n=60, 9, 6, 7 |
|
| CPS Secondary generalized n=10, 2, 0, 0 |
|
| Debilitating Seizures n=70, 12, 7, 7 |
|
| Title | Measurements |
|---|---|
|