Clinical trial NCT03742661: Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a New Diagnosis
Official title: Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a New Diagnosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Epilepsy
Lead sponsor: Brain Sentinel
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 5
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic Impact Form Questionnaire
timeFrame: Up to 5 months
Secondary outcomes:
measure: Personal Impact of Epilepsy Scale (PIES) Survey
timeFrame: 1 year
measure: VR-12 Survey
timeFrame: 1 year
measure: Personal Impact of Epilepsy Scale (PIES) Survey
timeFrame: 5 years
measure: VR-12 Survey
timeFrame: 5 years
measure: VA Administrative Data
timeFrame: 1 year
measure: VA Administrative Data
timeFrame: 5 years
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Lexington VA Medical Center
state: Kentucky
Study officials:
affiliation: Central Arkansas VA Medical Center
name: Bashir Shihabuddin, MD
role: PRINCIPAL_INVESTIGATOR
References: