- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03741205
Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a Recent Non-diagnostic EMU Visit
February 6, 2020 updated by: Brain Sentinel
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, who have had a recent non-diagnostic EMU stay.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is a veteran with a reported history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement.
- Subject has completed a non-diagnostic EMU stay within the last two years.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
SPEAC System
|
Surface Electromyography (sEMG) based seizure monitoring and alerting system
Other Names:
|
No Intervention: Standard of Care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
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).
|
1 year
|
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.
|
5 years
|
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 years
|
VA Administrative Data
Time Frame: 1 year
|
VA administrative data will be used to evaluate health outcomes.
|
1 year
|
VA Administrative Data
Time Frame: 5 years
|
VA administrative data will be used to evaluate health outcomes.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maria R Lopez, MD, Miami VA Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2020
Primary Completion (Anticipated)
January 1, 2021
Study Completion (Anticipated)
January 1, 2026
Study Registration Dates
First Submitted
August 2, 2018
First Submitted That Met QC Criteria
November 12, 2018
First Posted (Actual)
November 14, 2018
Study Record Updates
Last Update Posted (Actual)
February 7, 2020
Last Update Submitted That Met QC Criteria
February 6, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPT-05-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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