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

Study Overview
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Brief Summary
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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.

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

Conditions
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Epilepsy Intractable

Intervention / Treatment
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* Device: SPEAC System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Subjects suspected of experiencing one or more spells per month. Subjects has failed at least 3 anti-epileptic drugs (single or combination). Male or Female between the ages 22 to 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 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 prolonged period (up to five months), 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. The subject may not be enrolled in another Clinical Trial. The subject is homeless or in a home without a power supply.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participating physicians will recruit patients meeting the inclusion and exclusion criteria. Upon completion of screening and enrollment procedures study participants will be randomly assigned to one of two groups using a randomized call-in system: treatment or standard of care. Demographics will be obtained for both groups during this initial clinic visit. The treatment group will be prescribed the Brain Sentinel® SPEAC System for use in the home environment. Study Participants in the standard of care group will be given standard care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>SPEAC System | Device: SPEAC System<br>* Surface Electromyography (sEMG) based seizure monitoring and alerting system<br>* Other names: Brain Sentinel Monitoring and Alerting System;|
| No Intervention: Standard of Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Impact Form Questionnaire | 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. | Up to 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personal Impact of Epilepsy Scale (PIES) Survey | 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. | 1 year | 
| VR-12 Survey | This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY). | 1 year | 
| Personal Impact of Epilepsy Scale (PIES) Survey | 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. | 5 years | 
| VR-12 Survey | This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY). | 5 years | 
| VA Administrative Data | Healthcare utilization, medication, and cost data will be collected to determine VA administrative data will be used to evaluate health outcomes. | 1 year | 
| VA Administrative Data | VA administrative data will be used to evaluate health outcomes. | 5 years |