Clinical Utility of the SPEAC® System: A Case Series

Status:	Recruiting
Conditions:	Neurology, Epilepsy
Therapuetic Areas:	Neurology, Other
Healthy:	No
Age Range:	22 - 99
Updated:	11/10/2018
Start Date:	September 1, 2018
End Date:	May 2019

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.

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.

We found this trial at

sites

University of Texas Southwestern Medical Center

1801 Inwood Rd
Dallas, Texas 75390

(214) 645-3300