Assessing Brain Changes Throughout the ABI Wellness Program

• ClinicalTrials.gov Identifier: NCT03438851
• Recruitment Status: Recruiting
• First Posted: February 20, 2018
• Last Update Posted: August 22, 2019
• Sponsor: NeuroCatch Inc.
• Information provided by (Responsible Party): NeuroCatch Inc.

Tracking Information

• First Submitted Date: January 23, 2018
• First Posted Date: February 20, 2018
• Last Update Posted Date: August 22, 2019
• Actual Study Start Date: March 7, 2018
• Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 20, 2019)

• Tracking and comparison of neurophysiological changes (response size) to functional changes as participants complete 3 months of the ABIW program. [ Time Frame: 3 months ]
  Response size will be measured as amplitude in microvolts. Functional changes will be measured using a proprietary BrainEx Assessment that provides a category score from four cognitive programs of BrainEx.
• Tracking and comparison of neurophysiological changes (response timing) to functional changes as participants complete 3 months of the ABIW program. [ Time Frame: 3 months ]
  Response timing will be measured as latency in milliseconds. Functional changes will be measured using a proprietary BrainEx Assessment that provides a category score from four cognitive programs of BrainEx.

Original Primary Outcome Measures (submitted: February 16, 2018)

• Tracking and comparison of neurophysiological changes (response size) to functional changes as participants complete 3 months of the WCBH program. [ Time Frame: 3 months ]
  Response size will be measured as amplitude in microvolts. Functional changes will be measured using a proprietary BrainEx Assessment that provides a category score from four cognitive programs of BrainEx.
• Tracking and comparison of neurophysiological changes (response timing) to functional changes as participants complete 3 months of the WCBH program. [ Time Frame: 3 months ]
  Response timing will be measured as latency in milliseconds. Functional changes will be measured using a proprietary BrainEx Assessment that provides a category score from four cognitive programs of BrainEx.

Current Secondary Outcome Measures (submitted: February 16, 2018)

Collection and evaluation of adverse events and adverse device effects [ Time Frame: 3 months ]

Evaluate the tolerability and performance of the NeuroCatch Platform™ with individuals who have chronic cognitive deficits due to traumatic brain injury.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessing Brain Changes Throughout the ABI Wellness Program
• Official Title: Assessing Neurophysiological Changes in Individuals With Chronic Traumatic Brain Injury Symptoms Throughout a Full-time or Part-time Holistic Cognitive Rehabilitation Program: An Initial Assessment.

Brief Summary

Symptoms resulting from mild/moderate trauma to the brain are as varied as the individuals who sustain them. The currently held belief is that the majority of healing and functional recovery occurs within the first two years post injury. A large proportion of individuals who sustain mild/moderate brain injuries (mTBIs) do not fully recover, and continue to experience symptoms well beyond two years post injury. Cognitive rehabilitation programs have been shown to be somewhat effective in helping mTBI patients regain some functionality in these executive domains.

The purpose of the current study is to use an objective assessment of brain function to track changes during either a full-time or part-time holistic cognitive rehabilitation program, specifically the ABI Wellness (ABIW) program. The NeuroCatch Platform™ test will be used to assess brain functioning before, during and after 3 months in the ABIW program. The NeuroCatch Platform™ test uses electroencephalography (EEG) to measure event-related potential (ERP) signals produced by the brain, in response to an auditory stimulus. Three brain processes are examined with this test: Auditory sensation (ERP marker is the N100), Basic attention (ERP marker is the P300), and Cognitive processing (ERP marker is the N400).

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will self-select into one of two treatment conditions: a full-time intensive program or a part-time program. Participants in the full-time program will be asked to complete 4 experimental sessions with the NeuroCatch PlatformTM over the course of 3 months (i.e. one session/ month); whereas, participants in the part-time program will be asked to complete 3 scans over 3 months (i.e. one session/1.5 months).

Masking: None (Open Label)
Primary Purpose: Other

• Condition: Brain Injuries

Intervention

Device: NeuroCatch Platform™

NeuroCatch Platform™ consists of software and hardware that captures brain health information. The platform intends to provide a quick, portable and easy to use solution for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and event-related potential (ERP) information.

Study Arms

• Experimental: Full-time Cognitive Rehabilitation Program
  Participants in full-time program will be asked to complete 4 experimental sessions with the NeuroCatch Platform™ over the course of 3 months (i.e. one session/ month).
  Intervention: Device: NeuroCatch Platform™
• Experimental: Part-time Cognitive Rehabilitation Program
  Participants in the part-time program will be asked to complete 3 experimental sessions with the NeuroCatch Platform™ over 3 months (i.e. one session/1.5 months).
  Intervention: Device: NeuroCatch Platform™

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 16, 2018): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2022
• Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Enrolled in but not initiated the ABI Wellness program
2. Male or female, 19-65 years old inclusively
3. Normal hearing capabilities
4. Able to understand the informed consent form, study procedures and willing to participate in study
5. Able to keep eyes still for 6 minutes

Exclusion Criteria:

1. Clinically documented hearing issues (e.g. in-ear hearing problems, punctured ear drum, etc.)
2. Score of 7 or lower on the Mini Mental State Exam (MMSE) - Orientation subscale
3. Implanted pacemaker
4. Metal or plastic implants in skull
5. In-ear hearing aid or cochlear implant, hearing device
6. Recent (within last 6 months) acquired brain injury
7. History of other neurological disorder (e.g. brain cancer, dementia, multiple sclerosis, stroke, etc.)
8. Exposed to investigational drug or device 30 days prior to start in this study, or concurrent use of investigational drug or device while enrolled in this study
9. Not fluent in English language
10. Unable to provide informed consent
11. Previous participation in studies using the NeuroCatch Platform™
12. If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
13. History of seizures
14. Allergy to rubbing alcohol or EEG gel

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Christopher Smith; 250-715-8344; christophersmith@healthtechconnex.com

• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03438851
• Other Study ID Numbers: NCI_CogRehab_001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: NeuroCatch Inc.
• Study Sponsor: NeuroCatch Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jan Venter, MBChB MFamMed CCFP IFMCP; HealthTech Connex Inc. Centre for Neurology Studies

• PRS Account: NeuroCatch Inc.
• Verification Date: August 2019