Clinical Utility of the SPEAC® System: A Case Series

Not Applicable

• Conditions: Epilepsy
• Interventions: Device: SPEAC System

• Registration Number: NCT03484598
• Lead Sponsor: Brain Sentinel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-04-02
• Study Start: 2018-09-01
• Primary Completion: 2019-09-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-19
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPEAC Treatment Arm	SPEAC System	All study participants will be provided with a SPEAC System to use in their home environment.

Primary Outcome Measures

Name	Time	Method
Compare Seizure Frequency	1 year	We will compare self-reported seizure frequency to the seizure frequency measured by the SPEAC System.

Trial Locations

Locations (3)

The University of South Florida; 🇺🇸 Tampa, Florida, United States

Austin Epilepsy Care Center; 🇺🇸 Austin, Texas, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States