Trials / Completed
CompletedNCT02555410
Seizure Detection and Warning System in Epilepsy Patients
A Pivotal, Phase II Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 11 (actual)
- Sponsor
- Brain Sentinel · Academic / Other
- Sex
- All
- Age
- 2 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home.
Detailed description
The Brain Sentinel™ Seizure Detection and Warning System is intended for monitoring children and adults with a history or significant risk of generalized tonic-clonic seizures in the home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs, and for continuous monitoring (night time or any other time of day) of individuals due to their history or risk of generalized tonic-clonic seizures. The device will withstand activities of daily living including showers and sleep.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Brain Sentinel Seizure Detection and Warning System | A sEMG based automated seizure detection and warning system worn on the biceps |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2017-07-07
- Completion
- 2017-07-07
- First posted
- 2015-09-21
- Last updated
- 2017-07-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02555410. Inclusion in this directory is not an endorsement.