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

NCT03742661 | Unknown FDA Device

• 1 other identifier: CPT-03-2018
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• Personal Impact of Epilepsy Scale (PIES) Survey

  1 year

• VR-12 Survey

  1 year

• Personal Impact of Epilepsy Scale (PIES) Survey

  5 years

• VR-12 Survey

  5 years

• VA Administrative Data

  1 year

Study Arms (2)

Treatment Group

EXPERIMENTAL

SPEAC System

Device: SPEAC System

Standard of Care

NO INTERVENTION

Standard of Care

Interventions

SPEAC System DEVICE

Surface Electromyography (sEMG) based seizure monitoring and alerting system

Also known as: Brain Sentinel Monitoring and Alerting System

Treatment Group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brain Sentinel: lead

Study Sites (1)

Lexington VA Medical Center

Lexington, Kentucky, 40502, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Bashir Shihabuddin, MD

  Central Arkansas VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: November 15, 2018
• Study Start: November 2, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2026
• Last Updated: July 10, 2019

Record last verified: 2019-07

Locations

US (1)