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Improving Motor Stroke Recovery Using Patient-tailored Non-invasive Brain Stimulation

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sham TDCS
Anodal TDCS
Cathodal TDCS
Magnetic Resonance Imaging (MRI)
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring motor, rehabilitation, transcranial direct current stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • unilateral first time stroke in middle cerebral artery territory
  • greater 3 months post-stroke
  • able to raise arm onto a table from a seated position

Exclusion Criteria:

  • severe cognitive or comprehension deficits that may compromise informed consent or understanding of instructions
  • severe apraxia and neglect
  • neurodegenerative or psychiatric disease
  • contraindications to MRI and TDCS (e.g. metal in head, pacemaker, claustrophobia)

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brain Stimulation

Arm Description

Patients will receive, Sham TDCS, Anodal TDCS, Cathodal TDCS, and Magnetic Resonance Imaging (MRI).

Outcomes

Primary Outcome Measures

Change in movement time (seconds) for reaching after 1 session of TDCS
Change in accuracy of reaching (root mean square error) after 1 session of TDCS
Change in efficiency of reaching (number of velocity peaks) after 1 session of TDCS

Secondary Outcome Measures

Full Information

First Posted
May 25, 2015
Last Updated
June 1, 2022
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02473549
Brief Title
Improving Motor Stroke Recovery Using Patient-tailored Non-invasive Brain Stimulation
Official Title
Towards More Successful Clinical Trials: Using a Patient-tailored Approach in Brain Stimulation to Improve Recovery of Movements After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Many individuals are often left with problems moving their arm and hand, months to even years after a stroke. Recent progress in research suggests the application of non-invasive brain stimulation, such as transcranial direct current stimulation (TDCS), in conjunction with rehabilitation exercises can further improve a person's ability to move after stroke. However, the problem is that this doesn't work for everyone, and researchers do not know why. One reason may be that TDCS is currently applied using a one-size-fits-all approach. Researchers apply the same type of TDCS to everyone, assuming the stroke affects everyone in the same way. But, researchers know this is not the case. For example, each person will likely have different amounts of damage to brain regions that control movements. A better understanding of how the stroke uniquely affects a person's brain will help us to know which is the correct type of TDCS to apply for that person. Therefore, the objective of this research is to determine whether the amount of damage to brain regions that control movements can predict which type of TDCS will be more effective to help a person improve their ability to move. Participants will undergo 1 session of magnetic resonance imaging, and three sessions of TDCS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
motor, rehabilitation, transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brain Stimulation
Arm Type
Experimental
Arm Description
Patients will receive, Sham TDCS, Anodal TDCS, Cathodal TDCS, and Magnetic Resonance Imaging (MRI).
Intervention Type
Device
Intervention Name(s)
Sham TDCS
Intervention Description
Placebo stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity
Intervention Type
Device
Intervention Name(s)
Anodal TDCS
Intervention Description
Excitatory stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity
Intervention Type
Device
Intervention Name(s)
Cathodal TDCS
Intervention Description
Inhibitory stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
Participants will receive a MRI of their brain to allow the research investigators to determine how the stroke has affected regions of the brain processing movements.
Primary Outcome Measure Information:
Title
Change in movement time (seconds) for reaching after 1 session of TDCS
Time Frame
1 day
Title
Change in accuracy of reaching (root mean square error) after 1 session of TDCS
Time Frame
1 day
Title
Change in efficiency of reaching (number of velocity peaks) after 1 session of TDCS
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unilateral first time stroke in middle cerebral artery territory greater 3 months post-stroke able to raise arm onto a table from a seated position Exclusion Criteria: severe cognitive or comprehension deficits that may compromise informed consent or understanding of instructions severe apraxia and neglect neurodegenerative or psychiatric disease contraindications to MRI and TDCS (e.g. metal in head, pacemaker, claustrophobia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce Chen, PhD
Organizational Affiliation
Sunnybrook Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

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Improving Motor Stroke Recovery Using Patient-tailored Non-invasive Brain Stimulation

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