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

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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
3
sites
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Selim Benbadis, MD
Phone: 813-259-0826
University of South Florida The University of South Florida is a high-impact, global research university...
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Austin, Texas 78758
Principal Investigator: Sami Aboumatar, MD
Phone: 512-339-8831
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Kan Ding, MD
Phone: 214-648-9497
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, TX
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