Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 2 of 17 for:    seizure detection device

Seizure Detection and Warning System in Epilepsy Patients at the South Texas Comprehensive Epilepsy Center

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2015 by Brain Sentinel
Sponsor:
Information provided by (Responsible Party):
Brain Sentinel
ClinicalTrials.gov Identifier:
NCT02371200
First received: February 13, 2015
Last updated: February 26, 2015
Last verified: February 2015
  Purpose

Prospective study of an electromyography (EMG) based seizure detection and warning system for detecting generalized tonic-clonic (GTC) seizures.


Condition Intervention Phase
Epilepsy
Generalized Tonic-Clonic Seizures
Device: Brain Sentinel Seizure Detection and Warning System
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection andWarning System in Epilepsy Patients at the South Texas Comprehensive Epilepsy Center

Resource links provided by NLM:


Further study details as provided by Brain Sentinel:

Primary Outcome Measures:
  • Sensitivity of the Seizure Detection System [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
    The primary outcome measure for this clinical trial will be the sensitivity of the Brain Sentinel™ Seizure Detection Systems ability to detect GTC seizure activity in comparison to a Neurologist independent review of vEEG collected in an epilepsy monitoring unit.


Estimated Enrollment: 50
Study Start Date: March 2015
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: 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 Name: SPEAC System

Detailed Description:

This study "A Pivotal, Phase III Trial of Detecting generalized tonic-clonic seizures with a Seizure Detection and Warning System in Epilepsy Patients " is a phase III, pivotal, prospective study of an electromyography (EMG) based seizure detection and warning system (tentatively named Brain Sentinel™ Seizure Detection System) for detecting generalized tonic-clonic (GTC) seizures. 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. This is to facilitate a faster intervention to the GTC seizure, and to more accurately document GTC seizure frequency in a home, skilled nursing, or inpatient setting.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  1. Does not have a documented history of generalized seizures.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02371200

Contacts
Contact: Rose Hernandez, BS 855-275-5424 ext 107 rose.hernandez@brainsentinel.com
Contact: Kaylee Touchstone, AA 855-275-5424 ext 109 kaylee.touchstone@brainsentinel.com

Locations
United States, Texas
University Hospital Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Amy Saklad    210-567-8229    SAKLADA@uthscsa.edu   
Principal Investigator: Charles S Szabo, MD         
Sponsors and Collaborators
Brain Sentinel
Investigators
Principal Investigator: Charles Szabo, MD University Health System of San Antonio
  More Information

No publications provided

Responsible Party: Brain Sentinel
ClinicalTrials.gov Identifier: NCT02371200     History of Changes
Other Study ID Numbers: 1.0
Study First Received: February 13, 2015
Last Updated: February 26, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on March 01, 2015