Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a Recent Non-diagnostic EMU Visit
NCT ID: NCT03741205
Last Updated: 2020-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2020-07-01
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
DIAGNOSTIC
NONE
Study Groups
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Treatment Group
SPEAC System
SPEAC System
Surface Electromyography (sEMG) based seizure monitoring and alerting system
Standard of Care
Standard of Care
No interventions assigned to this group
Interventions
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SPEAC System
Surface Electromyography (sEMG) based seizure monitoring and alerting system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject has completed a non-diagnostic EMU stay within the last two years.
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 (up to five months), for a minimum of 30 hours/ week.
Exclusion Criteria
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.
22 Years
ALL
No
Sponsors
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Brain Sentinel
OTHER
Responsible Party
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Principal Investigators
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Maria R Lopez, MD
Role: PRINCIPAL_INVESTIGATOR
Miami VA Medical Center
Other Identifiers
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CPT-05-2018
Identifier Type: -
Identifier Source: org_study_id
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