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Neuroplastic Change in Myelin of the Brain (Myelin)

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
TRAIT Task
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring neuroplastic change, myelin

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of British ColumbiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stroke Group

Matched Healthy Control Group

Arm Description

Participants in the stroke group will complete 10 training sessions of the TRAIT task.

Participants in the Matched Healthy Control group will complete 10 sessions of the TRAIT task

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
August 27, 2013
Last Updated
January 9, 2017
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01937910
Brief Title
Neuroplastic Change in Myelin of the Brain
Acronym
Myelin
Official Title
Structural and Functional Correlates of Neuroplastic Change Associated With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
neuroplastic change, myelin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stroke Group
Arm Type
Experimental
Arm Description
Participants in the stroke group will complete 10 training sessions of the TRAIT task.
Arm Title
Matched Healthy Control Group
Arm Type
Active Comparator
Arm Description
Participants in the Matched Healthy Control group will complete 10 sessions of the TRAIT task
Intervention Type
Behavioral
Intervention Name(s)
TRAIT Task
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Myelin water fraction
Description
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)
Time Frame
Baseline and 30 days post baseline
Secondary Outcome Measure Information:
Title
Change in Fractional anisotropy
Description
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.
Time Frame
Baseline and 30 days post baseline
Other Pre-specified Outcome Measures:
Title
Change in Hemiparetic arm use measured by accelerometry
Description
Average daily movement counts indexed with accelerometers worn at the wrist
Time Frame
Baseline and 30 days post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamara Koren, MA
Phone
604-822-6886
Email
tamara.koren@ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lara Boyd, PhD; PT
Phone
604-827-3369
Email
lara.boyd@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara A Boyd, PT; PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander MacKay, PhD
First Name & Middle Initial & Last Name & Degree
Michael Borich, PhD
First Name & Middle Initial & Last Name & Degree
Lara Boyd, PT; PhD
First Name & Middle Initial & Last Name & Degree
Janice Eng, PhD
First Name & Middle Initial & Last Name & Degree
Negar Asdaghi, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Neuroplastic Change in Myelin of the Brain

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