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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Epilepsy
Title   Detecting Generalized Tonic-Clonic Seizures with a Seizure Detection and Warning System in Epilepsy Patients
Description   This study evaluates the accuracy of an electromyography (EMG) based seizure detection device and warning system, Night Watch( tm), for detecting generalized tonic-clonic seizures (GTCS). GTCS, or grand mal seizures.
IRB Number   Pro4231
Inclusion/Notes   INCLUSION:
  • Have a history of GTC seizures, either primary GTC or partial onset seizures with 2nd generalization.

  • Be admitted to a hospital for routine vEEG monitoring related to seizures.

  • Male or female between the ages of 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 an electrical power supply.

  • Be able to be discharged to a home where internet service is available.

  • If female and of childbearing potential, have 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.

  • Able to read, speak, and understand English.

EXCLUSION:
  • 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).

  • Pregnant female.

  • Subject/Caregiver is unable to provide consent.

  • Subject/Caregiver is not competent to follow home study procedures.

  • Homeless or a home without a power supply.

  • Resides in a home where internet service is not available.

  • Subject/Caregiver is unable to read, speak, or understand English.
Status   Recruiting
Location   Texas Health Presbyterian Hospital Dallas
Principal Name    Jay H Harvey DO
Contact Name   Shelley Long
Phone   (214) 345-8131

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