Clinical Utility of the SPEAC® System: A Case Series

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.

Study Overview

• Status: Unknown
• Conditions: Epilepsy
• Intervention / Treatment: Device: SPEAC System

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare Seizure Frequency	We will compare self-reported seizure frequency to the seizure frequency measured by the SPEAC System.	1 year

Collaborators and Investigators

• Sponsor: Brain Sentinel

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: CS-1.5-01.2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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