NCT01937910

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

August 27, 2013

Last Update Submit

January 9, 2017

Conditions

Stroke

Keywords

neuroplastic changemyelin

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change in Fractional anisotropy

    Baseline and 30 days post baseline

Other Outcomes (1)

  • Change in Hemiparetic arm use measured by accelerometry

    Baseline and 30 days post baseline

Study Arms (2)

Stroke Group

EXPERIMENTAL

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

Behavioral: TRAIT Task

Matched Healthy Control Group

ACTIVE COMPARATOR

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

Behavioral: TRAIT Task

Interventions

TRAIT TaskBEHAVIORAL

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.

Matched Healthy Control GroupStroke Group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Lara A Boyd, PT; PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamara Koren, MA

CONTACT

604-822-6886tamara.koren@ubc.ca

Lara Boyd, PhD; PT

CONTACT

604-827-3369lara.boyd@ubc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2013

First Posted

September 10, 2013

Study Start

September 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2018

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations

CA(1)