Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With REMI.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to test Epitel's™ Remote EEG Monitoring System's (REMI™) ability to record electroencephalography (EEG) of seizure events in an ambulatory setting for extended periods (14 - 28 days) in patients presenting with questionable seizure characterization. The main questions it aims to answer are: • Can more seizure events be recorded in fourteen (14) days than can be recorded in three (3) days? • Do treating clinicians find clinical value in extended fourteen (14) - twenty-eight (28) days of EEG? Participants will wear a portable EEG device (REMI) for fourteen (14) to twenty-eight (28) days in their home/community setting.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Patients have a reported history of seizures (epileptic, non-epileptic, or unknown),

• Have a minimum reported seizure rate of one every two weeks,

• Are prescribed an ambulatory EEG study as part of routine care,

• Is Male or Female between the ages of 18 and 70,

• Can understand and sign written informed consent, or have a legal guardian provide consent,

• The Patient (or Primary Caregiver) must be competent to follow all study procedures,

• The Patient must be willing to use the System for a prolonged period (up to 30 days), for a minimum of 20 hours/day.

Locations
United States
Florida
University of South Florida
RECRUITING
Tampa
South Carolina
Medical University of South Carolina
ENROLLING_BY_INVITATION
Charleston
Time Frame
Start Date: 2023-10-13
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 65
Related Therapeutic Areas
Sponsors
Leads: Epitel, Inc.

This content was sourced from clinicaltrials.gov