ClinicalTrials.gg
Sign In
Status unknownNCT03484598Updated Dec 19, 2019

Clinical Utility of the SPEAC® System: A Case Series

An interventional study of SPEAC System in Epilepsy, sponsored by Brain Sentinel. Status unknown at 3 sites in United States. Open to participants aged 22 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-12-19.

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

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
22 Years to 99 Years
Sex
All
01

Study summary

The primary objective is to collect preliminary data related to the clinical utility of the SPEAC System in patients with a history of motor seizures. This trial is primarily an observational investigation. This protocol describes a series of observational case studies. Each case study is intended to be interpreted independent from the other case studies. Self-reported seizure frequency will be compared to observed seizure frequency using the SPEAC System.

02

Conditions studied

  • Epilepsy

Browse trials for

03

In context

Epilepsy

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

This study's enrollment of 26 is below the median of 50 across 1,228 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

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.

04

Who can participate

Ages eligible
22 Years to 99 Years
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 has a reported history of motor seizures (epileptic or not or unknown) with upper extremity motor involvement.
  • The subject's first reported seizure must be within the last 5 years.
  • Male or Female between the ages 22 and 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 parent or 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 long period of time (up to 90 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    SPEAC Treatment Arm

    All study participants will be provided with a SPEAC System to use in their home environment.

    Device: SPEAC System

Interventions

  • DeviceSPEAC System

    A lightweight, non-invasive monitor that is placed on the belly of the biceps muscles to analyze surface electromyography (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures. It provides an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.

    Also known as: Brain Sentinel Seizure Monitoring and Alerting System

06

What researchers measure

Primary outcomes

  1. Compare Seizure Frequency

    We will compare self-reported seizure frequency to the seizure frequency measured by the SPEAC System.

    Time frame: 1 year

07

Study locations

3 sites
  • The University of South Florida
    Tampa, Florida 33620, United States
  • Austin Epilepsy Care Center
    Austin, Texas 78758, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03484598
Lead sponsor
Brain Sentinel
Responsible party
Sponsor
First posted
Apr 2, 2018
Start date
Sep 1, 2018
Primary completion
Sep 30, 2019
Completion
Apr 2020 (estimated)
Last update
Dec 19, 2019

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 Dec 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Epilepsy →

Other studies from this sponsor

Brain Sentinel

Start the discussion