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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

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.

Condition or disease Intervention/treatment Phase
Epilepsy Intractable Device: SPEAC System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
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
Official Title: Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Experimental: Treatment Group
SPEAC System
Device: SPEAC System
Surface Electromyography (sEMG) based seizure monitoring and alerting system
Other Name: Brain Sentinel Monitoring and Alerting System

No Intervention: Standard of Care



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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).

  5. 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.

  6. VA Administrative Data [ Time Frame: 5 years ]
    VA administrative data will be used to evaluate health outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Brain Sentinel
ClinicalTrials.gov Identifier: NCT03741192     History of Changes
Other Study ID Numbers: CPT-04-2018
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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