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Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs

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ClinicalTrials.gov Identifier: NCT03741192
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Brain Sentinel

Tracking Information
First Submitted Date  ICMJE August 2, 2018
First Posted Date  ICMJE November 14, 2018
Last Update Posted Date July 10, 2019
Estimated Study Start Date  ICMJE January 2020
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
Diagnostic Impact Form Questionnaire [ Time Frame: Up to 5 months ]
The physician will complete this questionnaire after each 30 days of device use to determine if information acquired will change the physician's assessment of the patient's seizures and their treatment plan.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
  • Personal Impact of Epilepsy Scale (PIES) Survey [ Time Frame: 1 year ]
    The PIES survey creates a composite score that can be used to assess the quality of life of patients with epilepsy, as well as sub-scales for assessing the quality of life in specific areas of life with epilepsy.
  • VR-12 Survey [ Time Frame: 1 year ]
    This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY).
  • Personal Impact of Epilepsy Scale (PIES) Survey [ Time Frame: 5 years ]
    The PIES survey creates a composite score that can be used to assess the quality of life of patients with epilepsy, as well as sub-scales for assessing the quality of life in specific areas of life with epilepsy.
  • VR-12 Survey [ Time Frame: 5 years ]
    This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY).
  • VA Administrative Data [ Time Frame: 1 year ]
    Healthcare utilization, medication, and cost data will be collected to determine VA administrative data will be used to evaluate health outcomes.
  • VA Administrative Data [ Time Frame: 5 years ]
    VA administrative data will be used to evaluate health outcomes.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs
Official Title  ICMJE Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs
Brief Summary This is an open label, randomized, prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure monitoring and alerting system for Veterans with seizures with upper extremity motor involvement, that are refractory to three or more antiepileptic drugs.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participating physicians will recruit patients meeting the inclusion and exclusion criteria. Upon completion of screening and enrollment procedures study participants will be randomly assigned to one of two groups using a randomized call-in system: treatment or standard of care.

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.

Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Epilepsy Intractable
Intervention  ICMJE Device: SPEAC System
Surface Electromyography (sEMG) based seizure monitoring and alerting system
Other Name: Brain Sentinel Monitoring and Alerting System
Study Arms  ICMJE
  • Experimental: Treatment Group
    SPEAC System
    Intervention: Device: SPEAC System
  • No Intervention: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 12, 2018)
58
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2026
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is a veteran with a reported history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization.
  2. Subjects suspected of experiencing one or more spells per month.
  3. Subjects has failed at least 3 anti-epileptic drugs (single or combination).
  4. Male or Female between the ages 22 to 99.
  5. If female and of childbearing potential, subject must agree to not become pregnant during the trial.
  6. 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.
  7. Subject or Primary Caregiver must be competent to follow all study procedures.
  8. 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:

  1. The subject cannot be pregnant, or nursing.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03741192
Other Study ID Numbers  ICMJE CPT-04-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brain Sentinel
Study Sponsor  ICMJE Brain Sentinel
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Brain Sentinel
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP