Status:
UNKNOWN
Clinical Utility of the SPEAC® System: A Case Series
Lead Sponsor:
Brain Sentinel
Conditions:
Epilepsy
Eligibility:
All Genders
22-99 years
Phase:
NA
Brief Summary
The primary objective is to collect preliminary data related to the clinical utility of the SPEAC System in patients with a history of motor seizures. This trial is primarily an observational investig...
Eligibility Criteria
Inclusion
- Subject has a reported history of motor seizures (epileptic or not or unknown) with upper extremity motor involvement.
- The subject's first reported seizure must be within the last 5 years.
- Male or Female between the ages 22 and 99.
- If female and of childbearing potential, subject must agree to not become pregnant during the trial.
- 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 or Primary Caregiver must be competent to follow all study procedures.
- Subject must be willing to use the Seizure Monitoring and Alerting System for a long period of time (up to 90 days), for a minimum of 30 hours/ week.
Exclusion
- The subject cannot be pregnant, or nursing.
- The subject cannot be sensitive or allergic to adhesives or tapes.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03484598
Start Date
September 1 2018
End Date
April 1 2020
Last Update
December 19 2019
Active Locations (3)
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1
The University of South Florida
Tampa, Florida, United States, 33620
2
Austin Epilepsy Care Center
Austin, Texas, United States, 78758
3
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390