Neuroplastic Change in Myelin of the Brain

Stroke Clinical Trial

— Myelin  

Official title:

Structural and Functional Correlates of Neuroplastic Change Associated With Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01937910
• Other study ID #: H13-01952
• Status: Recruiting
• Phase: N/A
• First received: August 27, 2013
• Last updated: January 9, 2017
• Start date: September 2014
• Est. completion date: September 2018

Study information

• Verified date: January 2017
• Source: University of British Columbia
• Contact: Tamara Koren, MA
• Phone: 604-822-6886
• Email: tamara.koren[@]ubc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: September 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Hemiparetic arm use measured by accelerometry	Average daily movement counts indexed with accelerometers worn at the wrist	Baseline and 30 days post baseline	No
Primary	Change in Myelin water fraction	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	No
Secondary	Change in Fractional anisotropy	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	No