Back to resultsClinical Utility of the SPEAC® System: A Case Series
Primary Purpose
Epilepsy
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPEAC System
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Subject has a reported history of motor seizures (epileptic or not or unknown) with upper extremity motor involvement.
- The subject's first reported seizure must be within the last 5 years.
- Male or Female between the ages 22 and 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 parent or 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 long period of time (up to 90 days), 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.
Sites / Locations
- The University of South Florida
- Austin Epilepsy Care Center
- University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SPEAC Treatment Arm
Arm Description
All study participants will be provided with a SPEAC System to use in their home environment.
Outcomes
Primary Outcome Measures
Compare Seizure Frequency
We will compare self-reported seizure frequency to the seizure frequency measured by the SPEAC System.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03484598
Brief Title
Clinical Utility of the SPEAC® System: A Case Series
Official Title
Clinical Utility of the SPEAC® System: A Case Series
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
April 2020 (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
The primary objective is to collect preliminary data related to the clinical utility of the SPEAC System in patients with a history of motor seizures. This trial is primarily an observational investigation. This protocol describes a series of observational case studies. Each case study is intended to be interpreted independent from the other case studies. Self-reported seizure frequency will be compared to observed seizure frequency using the SPEAC System.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPEAC Treatment Arm
Arm Type
Experimental
Arm Description
All study participants will be provided with a SPEAC System to use in their home environment.
Intervention Type
Device
Intervention Name(s)
SPEAC System
Other Intervention Name(s)
Brain Sentinel Seizure Monitoring and Alerting System
Intervention Description
A lightweight, non-invasive monitor that is placed on the belly of the biceps muscles to analyze surface electromyography (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures. It provides an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.
Primary Outcome Measure Information:
Title
Compare Seizure Frequency
Description
We will compare self-reported seizure frequency to the seizure frequency measured by the SPEAC System.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has a reported history of motor seizures (epileptic or not or unknown) with upper extremity motor involvement.
The subject's first reported seizure must be within the last 5 years.
Male or Female between the ages 22 and 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 parent or 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 long period of time (up to 90 days), 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.
Facility Information:
Facility Name
The University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Facility Name
Austin Epilepsy Care Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Utility of the SPEAC® System: A Case Series
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