Clinical Utility of the SPEAC® System: A Case Series
Status unconfirmed · Not applicable
Conditions studied: Epilepsy
In brief
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.
Key facts
- Study ID
- NCT03484598
- Run by
- Brain Sentinel
- People needed
- 26
- Starts
- 2018-09-01
- Expected to finish
- 2020-04-01
- Last updated by the study team
- 2019-12-19
Who can join
Age: 22 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.