Impact of SPEAC® System Data on Therapeutic Decisions Rel... | NCT03742661

Studies
Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a New Diagnosis

NCT03742661

Sponsor

Brain Sentinel

Status

Unknown status

Last Update Posted

Jul 10, 2019Actual

Enrollment

5Actual

Phase

Not Applicable

Conditions

Epilepsy

Interventions

SPEAC System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2, 2018Actual

Primary Completion Date

Jan 2021Estimated

Completion Date

Jan 2026Estimated

First Submitted Date

Aug 2, 2018

First Submission Date that Met QC Criteria

Nov 14, 2018

First Posted Date

Nov 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2019

Last Update Posted Date

Jul 10, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 a history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization, taking place in the home setting.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group	Experimental	SPEAC System	Device: SPEAC System
Standard of Care	No Intervention	Standard of Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPEAC System	Device	Surface Electromyography (sEMG) based seizure monitoring and alerting system	Treatment Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Up to 5 months

Secondary Outcomes

Measure	Description	Time Frame
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.	1 year
VR-12 Survey

Other Outcomes

Not provided

Eligibility Module

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 has failed fewer than 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 of time (up to 120 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.
The subject may not be enrolled in another Clinical Trial.
The subject is homeless or in a home without a power supply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bashir Shihabuddin, MD	Central Arkansas VA Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lexington VA Medical Center		Lexington	Kentucky	40502	United States

ID	Term
D004827	Epilepsy

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

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.