Back to resultsImpact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs
Primary Purpose
Epilepsy Intractable
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SPEAC System
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy Intractable
Eligibility Criteria
Inclusion Criteria:
- 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.
- Subjects suspected of experiencing one or more spells per month.
- Subjects has failed at least 3 anti-epileptic drugs (single or combination).
- Male or Female between the ages 22 to 99.
- If female and of childbearing potential, subject must agree to not become pregnant during the trial.
- 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.
- Subject or Primary Caregiver must be competent to follow all study procedures.
- 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:
- The subject cannot be pregnant, or nursing.
- The subject cannot be sensitive or allergic to adhesives or tapes.
- The subject may not be enrolled in another Clinical Trial.
- The subject is homeless or in a home without a power supply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment Group
Standard of Care
Arm Description
SPEAC System
Outcomes
Primary Outcome Measures
Diagnostic Impact Form Questionnaire
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
Personal Impact of Epilepsy Scale (PIES) Survey
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
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
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
This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY).
VA Administrative Data
Healthcare utilization, medication, and cost data will be collected to determine VA administrative data will be used to evaluate health outcomes.
VA Administrative Data
VA administrative data will be used to evaluate health outcomes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03741192
Brief Title
Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs
Official Title
Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brain Sentinel
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy Intractable
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
SPEAC System
Arm Title
Standard of Care
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
SPEAC System
Other Intervention Name(s)
Brain Sentinel Monitoring and Alerting System
Intervention Description
Surface Electromyography (sEMG) based seizure monitoring and alerting system
Primary Outcome Measure Information:
Title
Diagnostic Impact Form Questionnaire
Description
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.
Time Frame
Up to 5 months
Secondary Outcome Measure Information:
Title
Personal Impact of Epilepsy Scale (PIES) Survey
Description
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.
Time Frame
1 year
Title
VR-12 Survey
Description
This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY).
Time Frame
1 year
Title
Personal Impact of Epilepsy Scale (PIES) Survey
Description
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.
Time Frame
5 years
Title
VR-12 Survey
Description
This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY).
Time Frame
5 years
Title
VA Administrative Data
Description
Healthcare utilization, medication, and cost data will be collected to determine VA administrative data will be used to evaluate health outcomes.
Time Frame
1 year
Title
VA Administrative Data
Description
VA administrative data will be used to evaluate health outcomes.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Subjects suspected of experiencing one or more spells per month.
Subjects has failed at least 3 anti-epileptic drugs (single or combination).
Male or Female between the ages 22 to 99.
If female and of childbearing potential, subject must agree to not become pregnant during the trial.
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.
Subject or Primary Caregiver must be competent to follow all study procedures.
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:
The subject cannot be pregnant, or nursing.
The subject cannot be sensitive or allergic to adhesives or tapes.
The subject may not be enrolled in another Clinical Trial.
The subject is homeless or in a home without a power supply.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs
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