Seizure Detection and Warning System in Epilepsy Patients

NCT ID: NCT02555410

Last Updated: 2017-07-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-07-07

Brief Summary

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This is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home.

Detailed Description

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The Brain Sentinelâ„¢ Seizure Detection and Warning System is intended for monitoring children and adults with a history or significant risk of generalized tonic-clonic seizures in the home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs, and for continuous monitoring (night time or any other time of day) of individuals due to their history or risk of generalized tonic-clonic seizures. The device will withstand activities of daily living including showers and sleep.

Conditions

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Epilepsy Generalized Tonic-Clonic Seizures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DEVICE

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

Intervention Type DEVICE

Other Intervention Names

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SPEAC System

Eligibility Criteria

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Inclusion Criteria

1. Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
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

1. Does not have a documented history of generalized seizures.
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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brain Sentinel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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3.01P

Identifier Type: -

Identifier Source: org_study_id

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