Clinical Utility of the SPEAC® System: A Case Series

Epilepsy Clinical Trial

Official title:

Clinical Utility of the SPEAC® System: A Case Series

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03484598
• Other study ID #: CS-1.5-01.2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: April 2020

Study information

• Verified date: December 2019
• Source: Brain Sentinel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: April 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
United States	Austin Epilepsy Care Center	Austin	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	The University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Brain Sentinel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare Seizure Frequency	We will compare self-reported seizure frequency to the seizure frequency measured by the SPEAC System.	1 year