Assessing Brain Changes Throughout the ABI Wellness Program

Brain Injuries Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03438851
• Other study ID #: NCI_CogRehab_001
• Status: Terminated
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: April 21, 2020

Study information

• Verified date: March 2021
• Source: NeuroCatch Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 21, 2020
• Est. primary completion date: April 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Canada	HealthTech Connex Inc. Centre for Neurology Studies	Surrey	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
NeuroCatch Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tracking and comparison of neurophysiological changes (response size) to functional changes as participants complete 3 months of the ABIW program.	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.	3 months
Primary	Tracking and comparison of neurophysiological changes (response timing) to functional changes as participants complete 3 months of the ABIW program.	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.	3 months
Secondary	Collection and evaluation of adverse events and adverse device effects	Evaluate the tolerability and performance of the NeuroCatch Platform™ with individuals who have chronic cognitive deficits due to traumatic brain injury.	3 months