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

June 1, 2022 updated by: Sunnybrook Health Sciences Centre

Towards More Successful Clinical Trials: Using a Patient-tailored Approach in Brain Stimulation to Improve Recovery of Movements After Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brain Stimulation
Patients will receive, Sham TDCS, Anodal TDCS, Cathodal TDCS, and Magnetic Resonance Imaging (MRI).
Device: Sham TDCS
Placebo stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity
Device: Anodal TDCS
Excitatory stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity
Device: Cathodal TDCS
Inhibitory stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity
Device: Magnetic Resonance Imaging (MRI)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in movement time (seconds) for reaching after 1 session of TDCS
Time Frame: 1 day
1 day
Change in accuracy of reaching (root mean square error) after 1 session of TDCS
Time Frame: 1 day
1 day
Change in efficiency of reaching (number of velocity peaks) after 1 session of TDCS
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Joyce Chen, PhD, Sunnybrook Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

May 25, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimate)

June 16, 2015

Study Record Updates

Last Update Posted (Actual)

June 3, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 143-2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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