Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a New Diagnosis



Status:Recruiting
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:22 - Any
Updated:1/30/2019
Start Date:November 2, 2018
End Date:November 2024

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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.


Inclusion Criteria:

1. 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.

2. Subjects has failed fewer than 3 anti-epileptic drugs (single or combination).

3. Male or Female between the ages 22 to 99.

4. If female and of childbearing potential, subject must agree to not become pregnant
during the trial.

5. 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.

6. Subject or Primary Caregiver must be competent to follow all study procedures.

7. 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.

Exclusion Criteria:

1. The subject cannot be pregnant, or nursing.

2. The subject cannot be sensitive or allergic to adhesives or tapes.

3. The subject may not be enrolled in another Clinical Trial.

4. The subject is homeless or in a home without a power supply.
We found this trial at
1
site
Lexington, Kentucky 40502
Principal Investigator: Sally Mathias, MD
Phone: 859-381-5947
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Lexington, KY
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