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Device

SPEAC System for Seizure Monitoring

N/A
Waitlist Available
Led By Bashir Shihabuddin, MD
Research Sponsored by Brain Sentinel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects has failed fewer than 3 anti-epileptic drugs (single or combination).
If female and of childbearing potential, subject must agree to not become pregnant during the trial.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a device that monitors muscle activity to detect seizures in veterans with arm-involved motor seizures. The device alerts users when it detects unusual muscle movements, helping to identify seizures.

Who is the study for?
This trial is for veterans aged 22-99 with a history of motor seizures, who can consent to the study and commit to using the SPEAC System for up to 120 days. They must be able to follow procedures and use the system for at least 30 hours per week. It's not open to those in other trials, pregnant or nursing women, individuals allergic to adhesives or tapes, or without home power supply.
What is being tested?
The SPEAC System is being tested; it's an sEMG-based seizure monitoring device that alerts users about convulsive seizures. This study aims to see how this technology affects healthcare decisions and management for veterans with epilepsy in their homes.
What are the potential side effects?
Since the SPEAC System is a non-invasive monitoring device, side effects may include skin irritation due to adhesive use. There are no medicinal side effects as it does not involve drug intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have tried less than 3 epilepsy medications without success.
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I agree not to become pregnant during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diagnostic Impact Form Questionnaire
Secondary study objectives
Personal Impact of Epilepsy Scale (PIES) Survey
VA Administrative Data
VR-12 Survey

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment GroupExperimental Treatment1 Intervention
SPEAC System
Group II: Standard of CareActive Control1 Intervention
Standard of Care

Find a Location

Who is running the clinical trial?

Brain SentinelLead Sponsor
10 Previous Clinical Trials
638 Total Patients Enrolled
7 Trials studying Epilepsy
405 Patients Enrolled for Epilepsy
Bashir Shihabuddin, MDPrincipal InvestigatorCentral Arkansas VA Medical Center

Media Library

SPEAC System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03742661 — N/A
SPEAC System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03742661 — N/A
Epilepsy Research Study Groups: Standard of Care, Treatment Group
Epilepsy Clinical Trial 2023: SPEAC System Highlights & Side Effects. Trial Name: NCT03742661 — N/A
~1 spots leftby Nov 2025
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