Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs

Brain Sentinel

Status: Not yet enrolling

Conditions: Epilepsy Intractable

Treatments: Device: SPEAC System

Study type: Interventional

Funder types: Other

Identifiers

NCT03741192

CPT-04-2018

Details and patient eligibility

About

This is an open label, randomized, prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure monitoring and alerting system for Veterans with seizures with upper extremity motor involvement, that are refractory to three or more antiepileptic drugs.

Enrollment: 58 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is a veteran with a reported history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization.
2. Subjects suspected of experiencing one or more spells per month.
3. Subjects has failed at least 3 anti-epileptic drugs (single or combination).
4. Male or Female between the ages 22 to 99.
5. If female and of childbearing potential, subject must agree to not become pregnant during the trial.
6. Can understand and sign written informed consent or will have a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
7. Subject or Primary Caregiver must be competent to follow all study procedures.
8. Subject must be willing to use the Seizure Monitoring and Alerting System for a prolonged period (up to five months), for a minimum of 30 hours/ week.

Exclusion criteria

1. The subject cannot be pregnant, or nursing.
2. The subject cannot be sensitive or allergic to adhesives or tapes.
3. The subject may not be enrolled in another Clinical Trial.
4. The subject is homeless or in a home without a power supply.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Treatment Group

Experimental group

Description:

SPEAC System

Treatment:

Device: SPEAC System

Standard of Care

No Intervention group