Seizure Detection and Warning System in Epilepsy Patients
NCT ID: NCT02555410
Last Updated: 2017-07-12
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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COMPLETED
11 participants
OBSERVATIONAL
2013-01-31
2017-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Brain Sentinel Seizure Detection and Warning System
To test the usability of the Brain Sentinel Seizure Detection and Warning System(also known as the SPEAC system) in a patient home setting.
Brain Sentinel Seizure Detection and Warning System
A sEMG based automated seizure detection and warning system worn on the biceps
Interventions
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Brain Sentinel Seizure Detection and Warning System
A sEMG based automated seizure detection and warning system worn on the biceps
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female between the ages of 2-99.
3. Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
4. Be able to tolerate wearing the device on the upper arm.
5. If female and of childbearing potential, has a negative pregnancy test.
6. Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
7. Subject and/or Primary Caregiver must be competent to follow all study procedures.
8. Is able to read, speak and understand English.
Exclusion Criteria
2. The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm)
3. Pregnant female
4. Subject/Caregiver is unable to provide consent.
5. Subject/Caregiver is not competent to follow home study procedures.
6. The subject is homeless or in a home without a power supply.
2 Years
99 Years
ALL
No
Sponsors
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Brain Sentinel
OTHER
Responsible Party
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Principal Investigators
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Jose E. Cavazos, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Brain Sentinel
Locations
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Jose' E. Cavazos
San Antonio, Texas, United States
Countries
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Other Identifiers
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3.01P
Identifier Type: -
Identifier Source: org_study_id
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