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

Not Applicable

Not yet recruiting

• Conditions: Epilepsy Intractable
• Interventions: Device: SPEAC System

• Registration Number: NCT03741192
• Lead Sponsor: Brain Sentinel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-11-12
• Study First Posted: 2018-11-14
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-10
• Study Start: 2020-01
• Primary Completion: 2021-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	SPEAC System	SPEAC System

Primary Outcome Measures

Name	Time	Method
Diagnostic Impact Form Questionnaire	Up to 5 months	The physician will complete this questionnaire after each 30 days of device use to determine if information acquired will change the physician's assessment of the patient's seizures and their treatment plan.

Secondary Outcome Measures

Name	Time	Method
Personal Impact of Epilepsy Scale (PIES) Survey	5 years	The PIES survey creates a composite score that can be used to assess the quality of life of patients with epilepsy, as well as sub-scales for assessing the quality of life in specific areas of life with epilepsy.
VR-12 Survey	5 years	This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY).
VA Administrative Data	5 years	VA administrative data will be used to evaluate health outcomes.