Epilepsy
Conditions
Brief summary
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.
Interventions
DEVICESPEAC System
Surface Electromyography (sEMG) based seizure monitoring and alerting system
Sponsors
Brain Sentinel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Participating physicians will recruit patients meeting the inclusion and exclusion criteria. Upon completion of screening and enrollment procedures study participants will be randomly assigned to one of two groups using a randomized call-in system: treatment or standard of care. Demographics will be obtained for both groups during this initial clinic visit. The treatment group will be prescribed the Brain Sentinel® SPEAC System for use in the home environment. Study Participants in the standard of care group will be given standard care.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Impact Form Questionnaire | Up to 5 months | The physician will complete this questionnaire after each 30 days of device use to determine if information acquired will change the physician's assessment of the patient's seizures and their treatment plan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Personal Impact of Epilepsy Scale (PIES) Survey | 1 year | The PIES survey creates a composite score that can be used to assess the quality of life of patients with epilepsy, as well as sub-scales for assessing the quality of life in specific areas of life with epilepsy. |
| VR-12 Survey | 1 year | This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY). |
| VA Administrative Data | 1 year | VA administrative data will be used to evaluate health outcomes. |
Countries
United States
Outcome results
None listed