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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
Study Summary
This trial will test a device that uses sEMG to monitor for seizures and send alerts. It will be given to Veterans with a history of motor seizures who have upper extremity motor involvement and present with questionable spell characterization. The trial will take place in the home setting.
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.Check my eligibility
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.See study design
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 belowSelect...
I have tried less than 3 epilepsy medications without success.
Select...
I agree not to become pregnant during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diagnostic Impact Form Questionnaire
Secondary outcome measures
Personal Impact of Epilepsy Scale (PIES) Survey
VA Administrative Data
VR-12 Survey
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tried less than 3 epilepsy medications without success.I or my caregiver can follow all study instructions.I am a veteran with a history of seizures affecting my arms, and my seizure type is unclear.I am between 22 and 99 years old.I agree not to become pregnant during the trial.I am willing to use a Seizure Monitoring System for up to 120 days, at least 30 hours a week.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unoccupied spots left in this experiment?
"This clinical trial, which was initially listed on November 2nd 2018 and edited lastly on July 8th 2019, is no longer in search of participants. Nevertheless, other 287 medical trials are currently looking for patients."
Answered by AI
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