Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
Completed
Conditions studied: Epilepsy, Generalized Tonic-Clonic Seizures
In brief
Prospective study of an electromyography (EMG) based seizure detection and warning system for detecting generalized tonic-clonic (GTC) seizures.
Key facts
- Study ID
- NCT02371200
- Run by
- Brain Sentinel
- People needed
- 13
- Starts
- 2015-04-01
- Expected to finish
- 2018-02-01
- Last updated by the study team
- 2018-07-10
Who can join
Age: 2 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
- Is being admitted to a hospital for routine vEEG monitoring related to seizures.
- Male or female between the ages of 2-99.
- Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
- If female and of childbearing potential, has a negative pregnancy test.
- 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.
- Subject and/or Primary Caregiver must be competent to follow all study procedures.
- Is able to read, speak, and understand English.
You may not qualify if…
- Does not have a documented history of generalized seizures.
- Has not had a GTC seizure within the last year AND is not expected to have a reduction of anti-epileptic drugs during their hospital admission.
- Intracranial EEG electrodes are being used
- The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm).
- Pregnant female.
- Subject/Caregiver is unable to provide consent.
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
- University Hospital — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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