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

Austin Epilepsy Care Center

Austin, Texas 78758

Principal Investigator: Sami Aboumatar, MD

Phone: 512-339-8831

from

Austin, TX