A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients

Location:

Jacksonville, Fla., Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

The seizure detection and warning system is an ambulatory system designed to monitor and analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert caregivers that a seizure is occurring.

Who is eligible to participate?

Inclusion Criteria: - Have a history of generalized tonic-clonic seizures, either primary GTC or partial onset seizures with 2nd generalization. - Be admitted to a hospital for routine vEEG monitoring related to seizures. - Be ages 2-99. - Have an upper arm circumference which is adequate for proper fit of the EMG monitor or the monitor with arm adapter (approximately 16 cm). - Be able to be discharged to a home with electrical power supply. - Be able to be discharged to a home where internet service via phone, broadband, satellite or cellular phone service can be provided. - If female and of childbearing potential, have 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. - Able to read, speak, and understand English. Exclusion Criteria: - 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 - Upper arm circumference not adequate for proper fit of the EMG monitor even if the arm adapter is used (less than approximately 16cm). - If female, is pregnant. - Subject or Caregiver are unable to provide consent. - Subject or Caregiver not competent to follow home study procedures. - Homeless or home without power supply. - Resides in a home where internet service via phone, broadband, satellite or cellular phone service cannot be provided. - Subject or Caregiver is unable to read, speak, or understand English.

Last updated:

9/11/2014

NCT ID:

NCT01874600

IRB Number:

13-001007