Clinical Utility of the SPEAC® System: A Case Series

NCT03484598 | Unknown FDA Device

• 1 other identifier: CS-1.5-01.2018
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Compare Seizure Frequency

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

  1 year

Study Arms (1)

SPEAC Treatment Arm

EXPERIMENTAL

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

Device: SPEAC System

Interventions

SPEAC System DEVICE

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

SPEAC Treatment Arm

Eligibility Criteria

• Age: 22 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Brain Sentinel: lead

Study Sites (3)

The University of South Florida

Tampa, Florida, 33620, United States

Location

Austin Epilepsy Care Center

Austin, Texas, 78758, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: September 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: April 1, 2020
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)