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Altered mental status (AMS) is one of the most common reasons for inpatient neurology consultation. Non-convulsive status epilepticus (NCSE) is frequently on the differential diagnosis of the patient with AMS. NCSE becomes more refractory to treatment after one hour of seizure activity, making rapid identification and treatment of NCSE of great clinical importance. Currently, an electroencephalogram (EEG) technologist must be called in from home during non-workday hours in order to obtain a stat EEG. The investigators propose the time required for diagnosis of NCSE at Mayo Clinic can be significantly decreased with rapid placement of an EEG cap by the onsite neurology residents.
At the completion of neurology evaluation, if NCSE is in the differential diagnosis according to institution best practice, then consented participants will undergo placement of a large size, 20-channel EEG cap from Electro-Cap International with a Natus E-2-2520-26 electrode board adapter with initiation of recording. The placement of the EEG cap will be restricted to residents formally trained in its placement by an EEG tech. This study will only be performed during times when EEG techs are not available onsite for rapid placement of standard 21-channel EEG electrodes, such as during night-call shifts.
Prior to placement of EEG cap, evaluating staff member will request immediate standard-electrode EEG. The investigators will record time from neurology consultation request to placement of EEG cap as well as time from consultation request to obtaining a standard EEG. The investigators will also record time to confirmation or exclusion of NCSE. Initial diagnosis or exclusion of NCSE will be performed by on call resident, if the resident received prior training regarding EEG cap placement, and attending. Secondary quality assessment will be performed by two independent EEG interpreters blinded to clinical history. Secondary assessment will be qualified as acceptable or inacceptable interpretation based on whether greater or less than 50% of the recording is judged interpretable. Secondary assessment will also include interpretation of NCSE by a third independent reader if there is disagreement between first two. The number of patients excluded from the study will also be recorded, including the reason for exclusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EEG Cap | Other | Single arm study, where every participant gets assessed by EEG cap and then standard EEG. Some subjects may be treated with anti-seizure medications before standard EEG, due to ethical responsibility, if clear NCSE is identified on cap EEG. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG Cap | Device | Patient will be fitted with an EEG cap by the on-call neurology resident to assess for NCSE. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Difference Between EEG Cap and Standard EEG Results Reporting | The difference between EEG Cap results reporting time compared to Standard EEG results reporting time measured in minutes. | EEG order through 20 minutes of EEG recording time |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Whose EEG Cap Recordings Were Interpretable | The recording will be qualified as acceptable interpretation if greater than 50% of the recording is judged interpretable by board certified electroencephalographers. | approximately 15 minutes after completion of test |
| Number of Subjects Diagnosed With NCSE |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Tatum | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22577217 | Background | Ferlisi M, Shorvon S. The outcome of therapies in refractory and super-refractory convulsive status epilepticus and recommendations for therapy. Brain. 2012 Aug;135(Pt 8):2314-28. doi: 10.1093/brain/aws091. Epub 2012 May 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | EEG Cap | Single arm study, where every participant gets assessed by an electroencephalogram (EEG) cap and then standard EEG. Some subjects may be treated with anti-seizure medications before standard EEG, due to ethical responsibility, if clear Non-convulsive status epilepticus (NCSE) is identified on cap EEG. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EEG Cap | Single arm study, where every participant gets assessed by an electroencephalogram (EEG) cap and then standard EEG. Some subjects may be treated with anti-seizure medications before standard EEG, due to ethical responsibility, if clear NCSE is identified on cap EEG. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given. |
| 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 | Time Difference Between EEG Cap and Standard EEG Results Reporting | The difference between EEG Cap results reporting time compared to Standard EEG results reporting time measured in minutes. | Posted | Mean | Standard Deviation | minutes | EEG order through 20 minutes of EEG recording time |
|
Adverse events were collected for the duration of the EEG testing each subject, over a study period of 11 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EEG Cap | Single arm study, where every participant gets assessed by an electroencephalogram (EEG) cap and then standard EEG. Some subjects may be treated with anti-seizure medications before standard EEG, due to ethical responsibility, if clear NCSE is identified on cap EEG. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William O. Tatum | Mayo Clinic | 904-953-2498 | tatum.william@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2017 | Aug 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| D004828 | Epilepsies, Partial |
| D012640 | Seizures |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Subjects may be treated for NCSE based on EEG cap findings, but only following standard practice. The study is designed to identify NCSE, not to assess treatment of NCSE.
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There will be blinded EEG assessment in terms of the EEG readers.
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| Anti-seizure medication | Drug | Patients may be treated for NCSE or seizures based on EEG cap findings, if the findings are clear to an attending EEG reviewer. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given. |
|
| Standard EEG | Procedure | An electroencephalogram (EEG) is a test used to find problems related to electrical activity of the brain. An EEG tracks and records brain wave patterns. Small metal discs with thin wires (electrodes) are placed on the scalp, and then send signals to a computer to record the results. |
|
The number of subjects with suspected NCSE subsequently confirmed with NCSE after standard EEG. |
| approximately within 15 minutes after completion of test |
| Number of Subjects for Which the EEG Cap and Standard EEG Results Are in Agreement for the Diagnosis of NCSE | Concordance between cap and standard-electrode diagnostic assessments | approximately 24 hours after completion of both tests |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Percentage of Participants Whose EEG Cap Recordings Were Interpretable | The recording will be qualified as acceptable interpretation if greater than 50% of the recording is judged interpretable by board certified electroencephalographers. | Posted | Count of Participants | Participants | approximately 15 minutes after completion of test |
|
|
|
| Secondary | Number of Subjects Diagnosed With NCSE | The number of subjects with suspected NCSE subsequently confirmed with NCSE after standard EEG. | Posted | Count of Participants | Participants | approximately within 15 minutes after completion of test |
|
|
|
| Secondary | Number of Subjects for Which the EEG Cap and Standard EEG Results Are in Agreement for the Diagnosis of NCSE | Concordance between cap and standard-electrode diagnostic assessments | Posted | Count of Participants | Participants | approximately 24 hours after completion of both tests |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D004827 | Epilepsy |
| D002493 | Central Nervous System Diseases |