Brain InjuriesNCT03438851
Assessing Brain Changes Throughout the ABI Wellness Program
A study testing NeuroCatch Platform™ in people with Brain Injuries, run by NeuroCatch Inc. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- NeuroCatch Platform™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 7 Mar 2018to 21 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
HealthTech Connex Inc. Centre for Neurology Studies
Surrey, British Columbia, V3V 0C6
About this study
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.
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).
- Conditions
- Brain Injuries
- Being tested
- NeuroCatch Platform™
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroCatch Platform™Device
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 group | Role | What they receive |
|---|---|---|
| Full-time Cognitive Rehabilitation Program | Experimental | 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). Receives: Device: NeuroCatch Platform™ |
| Part-time Cognitive Rehabilitation Program | Experimental | 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). Receives: Device: NeuroCatch Platform™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start7 Mar 2018
- Primary completion21 Apr 2020
- Study completion21 Apr 2020
Why it stopped: NeuroCatch Platform became commercially available (Health Canada License approved) and can now be incorporated into the ABI Wellness Program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroCatch Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Venter, MBChB MFamMed CCFP IFMCP, Principal investigator, HealthTech Connex Inc. Centre for Neurology Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438851
- Sponsor's protocol ID
- NCI_CogRehab_001
- Status last verified
- Mar 2021
- First submitted
- 23 Jan 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03438851
- Acronym / sponsor ID
- NCI_CogRehab_001
- Conditions
- Brain Injuries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: NeuroCatch Platform became commercially available (Health Canada License approved) and can now be incorporated into the ABI Wellness Program
- Enrolment
- 7 participants (actual)
- Lead sponsor
- NeuroCatch Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Full-time Cognitive Rehabilitation Program | Experimental | Device: NeuroCatch Platform™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). |
| Part-time Cognitive Rehabilitation Program | Experimental | Device: NeuroCatch Platform™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). |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Full-time Cognitive Rehabilitation Program, Part-time Cognitive Rehabilitation Program |
Primary outcome
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.
1 secondary outcome
Collection and evaluation of adverse events and adverse device effects
Time frame: 3 months
Results and safety
The study was stopped early (reason given: NeuroCatch Platform became commercially available (Health Canada License approved) and can now be incorporated into the ABI Wellness Program). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Venter, MBChB MFamMed CCFP IFMCP principal investigator
HealthTech Connex Inc. Centre for Neurology Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroCatch Platform™ in people with Brain Injuries, run by NeuroCatch Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: NeuroCatch Platform became commercially available (Health Canada License approved) and can now be incorporated into the ABI Wellness Program). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracking and comparison of neurophysiological changes (response size) to functional changes as participants complete 3 months of the ABIW program. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.