Epilepsy, Motor Partial Clinical Trial
Official title:
Detecting PNES With Single-channel sEMG
| Verified date | December 2019 |
| Source | Brain Sentinel |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a prospective, comparative, multicenter study of subjects being admitted for standard of care therapy in Epilepsy Monitoring Units in the Veteran's Affair (VA) Medical Centers.
| Status | Active, not recruiting |
| Enrollment | 71 |
| Est. completion date | February 2020 |
| Est. primary completion date | June 21, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 22 Years to 99 Years |
| Eligibility |
Inclusion Criteria: 1. Subject has a history of suspected epileptic seizures with upper extremity motor involvement, or PNES with upper extremity motor involvement. 2. Is being admitted to a hospital for routine vEEG monitoring related to seizures. 3. Male or Female between the ages 22 to 99. 4. If female and of childbearing potential, has a negative pregnancy test and must not be nursing. 5. Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments. 6. Subject and/or Primary Caregiver must be competent to follow all study procedures. 7. Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study. Exclusion Criteria: - Intracranial EEG electrodes are being used. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Durham VAMC | Durham | North Carolina |
| United States | Michael E DeBakey VA Medical Center | Houston | Texas |
| United States | Hunter Holmes McGuire VA Medical Center | Richmond | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Brain Sentinel |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Test an independent group of epileptologist's ability to classify motor events between epileptic or non-epileptic using sEMG and audio. | To test the null hypothesis that three independent epileptologists categorize, by majority vote, epileptic seizures and psychogenic non-epileptic seizures (identified utilizing vEEG review) correctly in no more than 70% of cases using sEMG and audio. We aim to test the null hypothesis that the epileptologists categorize epileptic seizures and psychogenic non-epileptic seizures correctly in no more than 70% of cases. The observed rate of correct classification will be compared to the rate of 70% under the null hypothesis using a two-sided binomial exact test. | 1 year | |
| Secondary | To test the Brain Sentinel® Seizure Monitoring and Alerting System's ability to classify motor events as epileptic or non-epileptic. | Test the null hypothesis that the Brain Sentinel® Seizure Monitoring and Alerting System categorizes epileptic seizures and psychogenic non-epileptic seizures (identified utilizing vEEG review) correctly in no more than 70% of cases. We aim to test the null hypothesis that the Brain Sentinel® Seizure Monitoring and Alerting System's software categorizes epileptic seizures and psychogenic Nonepileptic seizures correctly in no more than 70% of cases. The observed rate of correct classification will be compared to the rate of 70% under the null hypothesis using a two-sided binomial exact test. | 1 Year |