Clincosm LogoSign in Get a demo

Clinical Utility of the SPEAC® System: A Case Series

Sponsor
Brain Sentinel (Other)
Overall Status
Unknown status
CT.gov ID
NCT03484598
Collaborator
(none)
26
Enrollment
3
Locations
1
Arm
19
Anticipated Duration (Months)
8.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: SPEAC System
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Clinical Utility of the SPEAC® System: A Case Series
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Sep 30, 2019
Anticipated Study Completion Date :
Apr 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: SPEAC Treatment Arm

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

Device: SPEAC 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.
Other Names:
  • Brain Sentinel Seizure Monitoring and Alerting System

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Compare Seizure Frequency [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    • The subject cannot be pregnant, or nursing.

    • The subject cannot be sensitive or allergic to adhesives or tapes.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of South Florida Tampa Florida United States 33620
    2 Austin Epilepsy Care Center Austin Texas United States 78758
    3 University of Texas Southwestern Medical Center Dallas Texas United States 75390

    Sponsors and Collaborators

    • Brain Sentinel

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brain Sentinel
    ClinicalTrials.gov Identifier:
    NCT03484598
    Other Study ID Numbers:
    • CS-1.5-01.2018
    First Posted:
    Apr 2, 2018
    Last Update Posted:
    Dec 19, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Epilepsy

    Study Results

    No Results Posted as of Dec 19, 2019