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Trial record 27 of 26598 for:    Change | Recruiting, Not yet recruiting, Available Studies

Neuroplastic Change in Myelin of the Brain (Myelin)

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ClinicalTrials.gov Identifier: NCT01937910
Recruitment Status : Recruiting
First Posted : September 10, 2013
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: TRAIT Task Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Structural and Functional Correlates of Neuroplastic Change Associated With Stroke
Study Start Date : September 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Experimental: Stroke Group
Participants in the stroke group will complete 10 training sessions of the TRAIT task.
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.

Active Comparator: Matched Healthy Control Group
Participants in the Matched Healthy Control group will complete 10 sessions of the TRAIT task
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937910


Contacts
Contact: Tamara Koren, MA 604-822-6886 tamara.koren@ubc.ca
Contact: Lara Boyd, PhD; PT 604-827-3369 lara.boyd@ubc.ca

Locations
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6T 1Z3
Sub-Investigator: Alexander MacKay, PhD         
Sub-Investigator: Michael Borich, PhD         
Principal Investigator: Lara Boyd, PT; PhD         
Sub-Investigator: Janice Eng, PhD         
Sub-Investigator: Negar Asdaghi, MD         
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Lara A Boyd, PT; PhD University of British Columbia

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01937910     History of Changes
Other Study ID Numbers: H13-01952
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of British Columbia:
neuroplastic change
myelin

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases