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Obtain baseline clinical outcome data (Stage 1) upon which to base a subsequent study (Stage 2) of the Model 106 VNS implantable pulse generator
Prospective, observational, un-blinded, 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, and 6-month follow-up. After the 6-month follow-up, patients will continue follow-up for safety for approximately two years or until final regulatory approval of the product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Model 106 VNS Therapy System | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M106 VNS Therapy System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the Effect Size Associated With Objective Measures and Patient Self-reports of Clinical Outcomes Including Seizure Frequency, Seizure Severity, Seizure Duration, Seizure Intensity, and Post-ictal Duration. | The purpose for determining the effect size was to power a stage 2 study. At the conclusion of stage 1 of the E-37 study, it was determined that another study would not be necessary as it would not provide incremental clinical benefit information above what has already been collected. Therefore, computation of effect size was not necessary. | Up to 18 Month Visit-End of Study |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Seizures Reported by Investigators and Triple Review | Seizure events were recorded during the EMU stay (only Automatic Stimulation Mode aka AutoStim ON) using vEEG and ECG to evaluate tachycardia detection algorithm performance. The threshold for the AutoStim feature (20-70%) was programmed for each subject, based upon the historical ictal elevation in heart rate for that subject, requiring the corresponding heart rate elevation above that of a moving baseline window. Number of seizures observed and reported by investigators during the EMU stay (several subjects had more than one type of seizure) were collected and also reviewed by three (3) independent and blinded reviewers for confirmation. Additionally, the reviewers identified new seizures while reviewing the study EMU stay vEEG. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Begnaud | Cyberonics, Inc. | Study Director |
| Robert Fisher, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
A total of (22) subjects were screened; (2) did not meet study criteria, (20) were treated/implanted with the AspireSR® VNS Therapy® System.
Eligible subjects were at least 12 years old, good general health suitable for VNS implant with refractory (drug-resistant) partial onset seizures and a history of ictal tachycardia, defined as heart rate above 100 beats per minute (bpm) during a seizure and at least a 55% increase or 35 bpm increase from baseline.
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| ID | Title | Description |
|---|---|---|
| FG000 | VNS Therapy - ITT Population | Subjects who were implanted with the AspireSR® VNS Therapy® System. The intent-to-treat (ITT) population is defined as all subjects with the VNS Therapy system implanted and the device had been turned on. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline Visit |
|
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| Epilepsy Monitoring Unit (EMU) Stay |
| Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Observed | 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 and non-seizure EEG segments were provided to independent reviewers to confirm seizure occurrence and define electrographic seizure onset times. Seizure onset times were then compared with observed M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. Threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). No subjects were assigned to settings 3 and 6 that had seizures with a corresponding heart rate increase of >= 50% and >= 20%, respectively. Number of participants is total number of subjects who experienced seizures during the EMU stay. Bootstrap confidence intervals using 3000 bootstrap samples. | Epilepsy Monitoring Unit (EMU) Stay |
| Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Modeled | 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. | Epilepsy Monitoring Unit (EMU) Stay |
| Assess Non-seizure Related Stimulation Rate Per Hour During EMU Stay and Stair Stepper Exercise Periods | Each day in the EMU, subjects exercised for up to 3 minutes stepping up and down at a submaximal effort level on a step stool. Subject's resting heart rate was compared with the calculated 85% of the patient's age-predicted maximum heart rate. This calculated heart rate was then used as termination criteria for the step test. Non-Seizure Detection Rate (previously known as Potential False Positive Rate) is defined as the total number of non-seizure detections summed for the group divided by the total evaluable monitoring time during the EMU. The non-seizure detection rate per hour was calculated at the various tachycardia detection settings for all subjects during EMU and during exercise activities (stair stepper). | Epilepsy Monitoring Unit (EMU) Stay |
| Assess Characterization of Seizures (Duration and Cessation) | 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 |
| Assesses 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 18 Month Visit-End of Study |
| Assess Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed 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 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 and 18 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. | Up to 18 Month Visit-End of Study |
| Assess Changes From Baseline in Quality of Life Based on Patient Completed Questionnaire (QOLIE-31-P) | Adult subjects (18 years and older) completed the Quality of Life in Epilepsy-Patient-Weighted (QOLIE-31-P) survey questionnaire at screening and safety follow-up visits. The range for QOLIE-31-P (Sub-domains) scale is 0-100. The higher the score the better quality of life. Mean QOLIE-31-P scores at 3, 6, 12 and 18 months were compared to baseline. MIC Thresholds as defined in Simon Borghs, Christine de la Loge, Joyce A. Cramer, defining minimally important change in QOLIE-31-P scores. | Up to 18 Month Visit-End of Study |
| Assess Changes From Baseline in Seizure Frequency | Seizure frequency was calculated at 3, 6,12 and 18 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 proportion of patients that achieved ≥50% seizure reduction per month from baseline by visit. | Up to 18 Month Visit-End of Study |
| Assess Percent Changes in Antiepileptic Drug (AED) Load From Baseline | AED load were collected and measured from baseline.The AED load is calculated as the sum of all ratios of the total daily dose of each medication taken on the day of the visit over the defined daily dose of the medication for the main indication according to the WHO database. Positive median value indicates increased drug load. | Up to 18 Month Visit-End of Study |
| Assess All Adverse Events to Outline the Tolerability Profile of the AspireSR® VNS Therapy® System | All adverse events (AEs) occurring during the study were collected and incidence rates tabulated by System Organ Class and Preferred Term utilizing MedDRA version 16.1 dictionary. The incidence profile was used to assess differences in near term tolerability rates relative to standard VNS Therapy. | From initial titration visit (approximately 2 weeks after implantation) up to End of Study |
| Evaluation of 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, the first day of EMU, the end of EMU, and the 6 month follow-up visit. Overall Usability was calculated as percentage of the users who found the overall usability of system to be "easy-2" or extremely easy-1". | Up to 6 Month Visit |
| Assess Changes in Healthcare Utilization: Inpatient Hospital Visits, Emergency Room Visits, Outpatient Hospitalizations and Physician Office Visits. | At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of unplanned inpatient hospitalizations, emergency room visits, outpatient hospitalizations, physician office visits. | Up to 18 Month Visit-End of Study |
| Assess Changes in Healthcare Utilization: Number of Nights Spent at the Hospital | At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of nights spent at the hospital. | Up to 18 Month Visit-End of Study |
| Assess Changes in Healthcare Utilization: Days Per Week Patients and Caregivers Could Not Work | At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of days per week of missed work because of health reasons. | Up to 18 Month Visit-End of Study |
| Assess Changes in Healthcare Utilization: Number of Hours Per Week Caregivers Spent Caring for Patients. | At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of hours per week caregivers spent caring for patients. | Up to 18 Month Visit-End of Study |
| Assess Changes in Healthcare Utilization: Number of Phone Calls to Physician | At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of phone calls to physicians. | Up to 18 Month Visit-End of Study |
| Stanford |
| California |
| United States |
| Tampa | Florida | United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | United States |
| Ann Arbor | Michigan | United States |
| Saint Paul | Minnesota | United States |
| Kansas City | Missouri | United States |
| Albany | New York | United States |
| Durham | North Carolina | United States |
| Pittsburgh | Pennsylvania | United States |
| Memphis | Tennessee | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Salt Lake City | Utah | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Implantation to 18-Month/End of Study |
|
Subjects implanted with VNS Therapy system
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | VNS Therapy (ITT Population) | Subjects who were implanted with the AspireSR® VNS Therapy® System. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Age, Customized | Median | Full Range | years |
| ||||||||||||||||||||||
| Age, Customized | Number | years |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Cognitive Status | Number | participants |
| |||||||||||||||||||||||
| Time from diagnosis to VNS therapy | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Time from diagnosis to VNS therapy | Median | Full Range | years |
| ||||||||||||||||||||||
| Previous brain or Epilepsy surgery | Number | participants |
| |||||||||||||||||||||||
| Etiology | Number | participants |
| |||||||||||||||||||||||
| Family history of seizures | Number | participants |
| |||||||||||||||||||||||
| Seizures with auras in past 2 months | Number | participants |
|
| 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 | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Summary of Seizures Reported by Investigators and Triple Review | Seizure events were recorded during the EMU stay (only Automatic Stimulation Mode aka AutoStim ON) using vEEG and ECG to evaluate tachycardia detection algorithm performance. The threshold for the AutoStim feature (20-70%) was programmed for each subject, based upon the historical ictal elevation in heart rate for that subject, requiring the corresponding heart rate elevation above that of a moving baseline window. Number of seizures observed and reported by investigators during the EMU stay (several subjects had more than one type of seizure) were collected and also reviewed by three (3) independent and blinded reviewers for confirmation. Additionally, the reviewers identified new seizures while reviewing the study EMU stay vEEG. | ITT Population: Consists of all patients in the safety population who have any EMU performance recorded data and experienced any seizures. | Posted | Number | Number of Seizures | Epilepsy Monitoring Unit (EMU) Stay |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Observed | 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 and non-seizure EEG segments were provided to independent reviewers to confirm seizure occurrence and define electrographic seizure onset times. Seizure onset times were then compared with observed M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. Threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). No subjects were assigned to settings 3 and 6 that had seizures with a corresponding heart rate increase of >= 50% and >= 20%, respectively. Number of participants is total number of subjects who experienced seizures during the EMU stay. Bootstrap confidence intervals using 3000 bootstrap samples. | ITT Population (Investigator Reported Seizures + Triple Review). N= represents total number of seizures. | Posted | Number | 95% Confidence Interval | Percent of True Positive Seizures | Epilepsy Monitoring Unit (EMU) Stay |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Modeled | 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. | ITT Population (Investigator Reported Seizures + Triple Review). N= represents total number of seizures. | Posted | Number | 95% Confidence Interval | Percent of True Positive Seizures | Epilepsy Monitoring Unit (EMU) Stay |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Assess Non-seizure Related Stimulation Rate Per Hour During EMU Stay and Stair Stepper Exercise Periods | Each day in the EMU, subjects exercised for up to 3 minutes stepping up and down at a submaximal effort level on a step stool. Subject's resting heart rate was compared with the calculated 85% of the patient's age-predicted maximum heart rate. This calculated heart rate was then used as termination criteria for the step test. Non-Seizure Detection Rate (previously known as Potential False Positive Rate) is defined as the total number of non-seizure detections summed for the group divided by the total evaluable monitoring time during the EMU. The non-seizure detection rate per hour was calculated at the various tachycardia detection settings for all subjects during EMU and during exercise activities (stair stepper). | ITT Population. 5 participants analyzed for >=70%, 4 for >=60% setting, 8 for >=50% setting, 2 for >=40% setting, 1 for the >=30% setting. | Posted | Number | 95% Confidence Interval | detections per hour | Epilepsy Monitoring Unit (EMU) Stay |
| |||||||||||||||||||||||||||||||||||
| Secondary | Assess Characterization of Seizures (Duration and Cessation) | 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 | Posted | Number | Percent of Seizures Ended During Stim | Epilepsy Monitoring Unit (EMU) Stay | Seizures Treated | Participants |
| ||||||||||||||||||||||||||||||||||
| Secondary | Assesses 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 18 Month Visit-End of Study |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Assess Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed 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 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 and 18 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. | ITT Population | Posted | Mean | Standard Deviation | Units on a Scale | Up to 18 Month Visit-End of Study |
| |||||||||||||||||||||||||||||||||||
| Secondary | Assess Changes From Baseline in Quality of Life Based on Patient Completed Questionnaire (QOLIE-31-P) | Adult subjects (18 years and older) completed the Quality of Life in Epilepsy-Patient-Weighted (QOLIE-31-P) survey questionnaire at screening and safety follow-up visits. The range for QOLIE-31-P (Sub-domains) scale is 0-100. The higher the score the better quality of life. Mean QOLIE-31-P scores at 3, 6, 12 and 18 months were compared to baseline. MIC Thresholds as defined in Simon Borghs, Christine de la Loge, Joyce A. Cramer, defining minimally important change in QOLIE-31-P scores. | ITT Population | Posted | Mean | Standard Deviation | Units on a Scale | Up to 18 Month Visit-End of Study |
| |||||||||||||||||||||||||||||||||||
| Secondary | Assess Changes From Baseline in Seizure Frequency | Seizure frequency was calculated at 3, 6,12 and 18 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 proportion 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 18 Month Visit-End of Study |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Assess Percent Changes in Antiepileptic Drug (AED) Load From Baseline | AED load were collected and measured from baseline.The AED load is calculated as the sum of all ratios of the total daily dose of each medication taken on the day of the visit over the defined daily dose of the medication for the main indication according to the WHO database. Positive median value indicates increased drug load. | ITT Population | Posted | Median | Full Range | Percent Change | Up to 18 Month Visit-End of Study |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Estimate the Effect Size Associated With Objective Measures and Patient Self-reports of Clinical Outcomes Including Seizure Frequency, Seizure Severity, Seizure Duration, Seizure Intensity, and Post-ictal Duration. | The purpose for determining the effect size was to power a stage 2 study. At the conclusion of stage 1 of the E-37 study, it was determined that another study would not be necessary as it would not provide incremental clinical benefit information above what has already been collected. Therefore, computation of effect size was not necessary. | Posted | Up to 18 Month Visit-End of Study |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Assess All Adverse Events to Outline the Tolerability Profile of the AspireSR® VNS Therapy® System | All adverse events (AEs) occurring during the study were collected and incidence rates tabulated by System Organ Class and Preferred Term utilizing MedDRA version 16.1 dictionary. The incidence profile was used to assess differences in near term tolerability rates relative to standard VNS Therapy. | ITT Population | Posted | Number | Number of Participants | From initial titration visit (approximately 2 weeks after implantation) up to End of Study |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Evaluation of 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, the first day of EMU, the end of EMU, and the 6 month follow-up visit. Overall Usability was calculated as percentage of the users who found the overall usability of system to be "easy-2" or extremely easy-1". | ITT Population | Posted | Number | Percentage of Participants Rated 1 or 2 | Up to 6 Month Visit |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Assess Changes in Healthcare Utilization: Inpatient Hospital Visits, Emergency Room Visits, Outpatient Hospitalizations and Physician Office Visits. | At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of unplanned inpatient hospitalizations, emergency room visits, outpatient hospitalizations, physician office visits. | ITT Population | Posted | Median | Full Range | Visits | Up to 18 Month Visit-End of Study |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Assess Changes in Healthcare Utilization: Number of Nights Spent at the Hospital | At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of nights spent at the hospital. | ITT Population | Posted | Median | Full Range | Nights | Up to 18 Month Visit-End of Study |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Assess Changes in Healthcare Utilization: Days Per Week Patients and Caregivers Could Not Work | At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of days per week of missed work because of health reasons. | ITT Population | Posted | Median | Full Range | Days Per Week | Up to 18 Month Visit-End of Study |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Assess Changes in Healthcare Utilization: Number of Hours Per Week Caregivers Spent Caring for Patients. | At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of hours per week caregivers spent caring for patients. | ITT Population | Posted | Median | Full Range | Hours Per Week | Up to 18 Month Visit-End of Study |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Assess Changes in Healthcare Utilization: Number of Phone Calls to Physician | At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of phone calls to physicians. | ITT Population | Posted | Median | Full Range | Phone Calls | Up to 18 Month Visit-End of Study |
|
|
After Implantation up to 18 months-End of Study
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 end of study for all subjects treated/implanted with the AspireSR® VNS Therapy® system. Only the most common AEs (> 5%) are reported in the AE data table. | 3 | 20 | 14 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incision wound cellulitis | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Post-procedural hematoma | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Altered State of Consciousness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Subdural Hematoma | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment | 1 Related to Implantation Procedure, 5 Related to VNS Therapy Stimulation, 1 Related to Both VNS Therapy Stimulation and Implantation Procedure |
|
| Convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment | 2 Related to VNS Therapy Stimulation |
|
| Stress | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment | 1 Reported to VNS Therapy Stimulation |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment | All Related to Implantation Procedure |
|
| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment | 1 Related to VNS Therapy Stimulation |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment | Related to VNS Therapy Stimulation |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Umblical Hernia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
The small sample size and the absence of randomization did not allow conclusions about whether the AutoStim alone, or the combination of AutoStim and traditional VNS therapy modes, or some other factor was a cause of the observed beneficial effects.
Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted for sponsor's review if such publication contains Confidential Information or will adversely affect any intellectual property or proprietary right of the sponsor. The sponsor can require changes to the communication, but cannot extend the embargo set forth in the study agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bita Najimipour, Clinical Study Manager | Cyberonics, Inc. | (281) 228-7370 | bita.najimipour@cyberonics.com |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| 40-49 years |
|
| 50-59 years |
|
| 60 years or older |
|
| Hispanic or Latino |
|
| Cryptogenic |
|
|
| Simple Partial |
|
| Complex Partial |
|
| Secondarily Generalized |
|
| Sub-Clinical |
|
| Unclassified |
|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Sub-Clinical Seizures |
During AutoStim Course in The EMU |
| OG005 | Unknown Seizures | During AutoStim Course in The EMU |
|
|
|
|
| SSQ Scores at 18 Months |
Change From Baseline at Each Category |
|
|
|
Change From Baseline at Each Category
|
|
|
|
|
|
|
| OG003 | 6-Month Visit | Users' Overall Assessment of Device Usability |
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|