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 seizures with upper extremity motor involvement, that are refractory to three or more antiepileptic drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
58
Surface Electromyography (sEMG) based seizure monitoring and alerting system
Diagnostic Impact Form Questionnaire
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.
Time frame: Up to 5 months
Personal Impact of Epilepsy Scale (PIES) Survey
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.
Time frame: 1 year
VR-12 Survey
This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY).
Time frame: 1 year
Personal Impact of Epilepsy Scale (PIES) Survey
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.
Time frame: 5 years
VR-12 Survey
This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY).
Time frame: 5 years
VA Administrative Data
Healthcare utilization, medication, and cost data will be collected to determine VA administrative data will be used to evaluate health outcomes.
Time frame: 1 year
VA Administrative Data
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VA administrative data will be used to evaluate health outcomes.
Time frame: 5 years