Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a New Diagnosis
Status unconfirmed · Not applicable
Conditions studied: Epilepsy
In brief
This is an open label, randomized, prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure monitoring and alerting system for Veterans with a history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization, taking place in the home setting.
Key facts
- Study ID
- NCT03742661
- Run by
- Brain Sentinel
- People needed
- 5
- Starts
- 2018-11-02
- Expected to finish
- 2026-01-01
- Last updated by the study team
- 2019-07-10
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is a veteran with a reported history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization.
- Subjects has failed fewer than 3 anti-epileptic drugs (single or combination).
- Male or Female between the ages 22 to 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 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 prolonged period of time (up to 120 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.
- The subject may not be enrolled in another Clinical Trial.
- The subject is homeless or in a home without a power supply.
Where it is running
- Lexington VA Medical Center — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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