Status unknownNCT03742661Updated Jul 10, 2019

Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a New Diagnosis

An interventional study of SPEAC System in Epilepsy, sponsored by Brain Sentinel. Status unknown at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2019-07-10.

Sponsored by Brain Sentinel · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 5
Allocation: Randomized
Ages: 22 Years and older
Sex: All

Study 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 a history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization, taking place in the home setting.

Conditions studied

Epilepsy

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Epilepsy 1,842

In context

Epilepsy

1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.

This study's enrollment of 5 is below the median of 50 across 1,228 interventional studies indexed under Epilepsy.

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Lead sponsor

Brain Sentinel is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 22 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 has failed fewer than 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 of time (up to 120 days), for a minimum of 30 hours/ week.

Exclusion criteria

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.

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 5 participants (actual)

Study arms

Experimental
Treatment Group
SPEAC System
Device: SPEAC System
No intervention
Standard of Care
Standard of Care

Interventions

DeviceSPEAC System
Surface Electromyography (sEMG) based seizure monitoring and alerting system
Also known as: Brain Sentinel Monitoring and Alerting System

What researchers measure

Primary outcomes

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.
Time frame: Up to 5 months

Secondary outcomes

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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 5 years
VA Administrative Data
VA administrative data will be used to evaluate health outcomes.
Time frame: 1 year
VA Administrative Data
VA administrative data will be used to evaluate health outcomes.
Time frame: 5 years

Study locations

1 site

Lexington VA Medical Center
Lexington, Kentucky 40502, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03742661
Lead sponsor: Brain Sentinel
Responsible party: Sponsor
First posted: Nov 15, 2018
Start date: Nov 2, 2018
Primary completion: Jan 2021 (estimated)
Completion: Jan 2026 (estimated)
Last update: Jul 10, 2019

Study contacts

Bashir Shihabuddin, MD

principal investigator · Central Arkansas VA Medical Center

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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