- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01937910
Neuroplastic Change in Myelin of the Brain (Myelin)
January 9, 2017 updated by: University of British Columbia
Structural and Functional Correlates of Neuroplastic Change Associated With Stroke
The main goal of this research is to advance understanding of how stroke changes both the structure and function of the brain.
The investigators will determine which is the key driver of recovery of arm function after stroke: changes in the structure of the brain or changes in how brain regions interact with one another.
Study Overview
Detailed Description
The main goal of this research is to advance understanding of how stroke changes both the structure and function of the brain.
Further, the investigators will determine which is the key driver of recovery of arm function after stroke: changes in the structure of the brain or changes in how brain regions interact with one another.
Together, these data will advance the investigators understanding of how neural systems support recovery from stroke.
The investigators will use a MRI technique that allows us to assess the health of a brain structure called myelin.
This structure is important as it allows information to travel down nerves faster; the more myelin the quicker the signal can be conducted.
The investigators aim is to test whether or not movement training can restore myelin in the brain.
If movement training does restore myelin in the brain, the investigators will have identified an important new target for rehabilitation interventions.
Study Type
Interventional
Enrollment (Anticipated)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada, V6T 1Z3
- Recruiting
- University of British Columbia
-
Sub-Investigator:
- Alexander MacKay, PhD
-
Sub-Investigator:
- Michael Borich, PhD
-
Principal Investigator:
- Lara Boyd, PT; PhD
-
Sub-Investigator:
- Janice Eng, PhD
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Sub-Investigator:
- Negar Asdaghi, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- individuals aged 40-75
- movement-related deficits associated with a middle cerebral artery stroke
- first time stroke affecting the corona radiata and/or internal capsule
- Fugl-Meyer upper extremity motor score of at least 15 but not greater than 55.
Exclusion Criteria:
- outside the age range of 40-75
- show signs of dementia (score < 24 on the Montreal Cognitive Assessment)
- have aphasia (score < 13 on the Frenchay Aphasia Screen)
- history of head trauma, a major psychiatric diagnosis, neurodegenerative disorder or substance abuse;
- taking any drugs (GABAergic, N-methyl-D-aspartate A-receptor (NMDA) antagonist) known to influence neuroplasticity;
- report contraindications to MRI (see supporting documents)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stroke Group
Participants in the stroke group will complete 10 training sessions of the TRAIT task.
|
Increased paretic arm will be manipulated through the performance of a semi-immersive virtual reality-based intercept and release task called TRAIT (TRack And Intercept Task), which is performed in an interactive environment.
TRAIT employs an open source Kinect sensor, which tracks 3-D joint movement.
Participants are asked to control an on-screen icon using movements of their paretic arm to intercept a moving object as it emerges from the side of a computer screen.
Once intercepted, they must accurately throw the object to hit a target.
Participants move up through 10 levels of the game as their skill improves.
Participants will complete 10 TRAIT training sessions in 4 weeks for a total of 10,000 experimental movements.
|
Active Comparator: Matched Healthy Control Group
Participants in the Matched Healthy Control group will complete 10 sessions of the TRAIT task
|
Increased paretic arm will be manipulated through the performance of a semi-immersive virtual reality-based intercept and release task called TRAIT (TRack And Intercept Task), which is performed in an interactive environment.
TRAIT employs an open source Kinect sensor, which tracks 3-D joint movement.
Participants are asked to control an on-screen icon using movements of their paretic arm to intercept a moving object as it emerges from the side of a computer screen.
Once intercepted, they must accurately throw the object to hit a target.
Participants move up through 10 levels of the game as their skill improves.
Participants will complete 10 TRAIT training sessions in 4 weeks for a total of 10,000 experimental movements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Myelin water fraction
Time Frame: Baseline and 30 days post baseline
|
Myelin water fraction (MWF) is the area of the short T2 component (15-35ms) divided by the total T2 distribution expressed as a percentage (MWF% = MWF*100)
|
Baseline and 30 days post baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fractional anisotropy
Time Frame: Baseline and 30 days post baseline
|
Diffusion properties will be defined by calculating a 6-element tensor ellipsoid to provide both the magnitude and direction of diffusivity in a local orthogonal coordinate system within each voxel.
Fractional anisotropy (FA) will be calculated to provide an index of microstructural white matter integrity.
|
Baseline and 30 days post baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hemiparetic arm use measured by accelerometry
Time Frame: Baseline and 30 days post baseline
|
Average daily movement counts indexed with accelerometers worn at the wrist
|
Baseline and 30 days post baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lara A Boyd, PT; PhD, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Anticipated)
September 1, 2017
Study Completion (Anticipated)
September 1, 2018
Study Registration Dates
First Submitted
August 27, 2013
First Submitted That Met QC Criteria
September 4, 2013
First Posted (Estimate)
September 10, 2013
Study Record Updates
Last Update Posted (Estimate)
January 10, 2017
Last Update Submitted That Met QC Criteria
January 9, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H13-01952
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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