Epilepsy
Conditions
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 investigation. This protocol describes a series of observational case studies. Each case study is intended to be interpreted independent from the other case studies. Self-reported seizure frequency will be compared to observed seizure frequency using the SPEAC System.
Interventions
DEVICESPEAC System
A lightweight, non-invasive monitor that is placed on the belly of the biceps muscles to analyze surface electromyography (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures. It provides an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.
Sponsors
Brain Sentinel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* The subject cannot be pregnant, or nursing. * The subject cannot be sensitive or allergic to adhesives or tapes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare Seizure Frequency | 1 year | We will compare self-reported seizure frequency to the seizure frequency measured by the SPEAC System. |
Countries
United States
Outcome results
None listed