Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
NCT ID: NCT02371200
Last Updated: 2018-07-10
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
13 participants
OBSERVATIONAL
2015-04-30
2018-02-28
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
This study will compare accuracy of seizure detection by the study device to simultaneously collected data of seizure detection by video EEG.
Brain Sentinel Seizure Detection and Warning System
The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity.
Interventions
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Brain Sentinel Seizure Detection and Warning System
The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Is being admitted to a hospital for routine vEEG monitoring related to seizures.
3. Male or female between the ages of 2-99.
4. Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
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. Has not had a GTC seizure within the last year AND is not expected to have a reduction of anti-epileptic drugs during their hospital admission.
3. Intracranial EEG electrodes are being used
4. The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm).
5. Pregnant female.
6. Subject/Caregiver is unable to provide consent.
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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Charles Szabo, MD
Role: PRINCIPAL_INVESTIGATOR
University Health System of San Antonio
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
University Hospital
San Antonio, Texas, United States
Countries
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Other Identifiers
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GTC-1.5-09.2015
Identifier Type: -
Identifier Source: org_study_id
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