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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy Intractable
• Intervention / Treatment: Device: SPEAC System

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	VA administrative data will be used to evaluate health outcomes.	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

Collaborators and Investigators

• Sponsor: Brain Sentinel

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Drug Resistant Epilepsy
• Other Study ID Numbers: CPT-04-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes