Status:
TERMINATED
Assessing Brain Changes Throughout the ABI Wellness Program
Lead Sponsor:
NeuroCatch Inc.
Conditions:
Brain Injuries
Eligibility:
All Genders
19-65 years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- Enrolled in but not initiated the ABI Wellness program
- Male or female, 19-65 years old inclusively
- Normal hearing capabilities
- Able to understand the informed consent form, study procedures and willing to participate in study
- Able to keep eyes still for 6 minutes
Exclusion
- Clinically documented hearing issues (e.g. in-ear hearing problems, punctured ear drum, etc.)
- Score of 7 or lower on the Mini Mental State Exam (MMSE) - Orientation subscale
- Implanted pacemaker
- Metal or plastic implants in skull
- In-ear hearing aid or cochlear implant, hearing device
- Recent (within last 6 months) acquired brain injury
- History of other neurological disorder (e.g. brain cancer, dementia, multiple sclerosis, stroke, etc.)
- 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
- Not fluent in English language
- Unable to provide informed consent
- Previous participation in studies using the NeuroCatch Platform™
- If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
- History of seizures
- Allergy to rubbing alcohol or EEG gel
Key Trial Info
Start Date :
March 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03438851
Start Date
March 7 2018
End Date
April 21 2020
Last Update
March 18 2021
Active Locations (1)
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1
HealthTech Connex Inc. Centre for Neurology Studies
Surrey, British Columbia, Canada, V3V 0C6