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

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Completed
CT.gov ID
NCT02473549
Collaborator
(none)
25
1
1
45.9
0.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Sham TDCS
  • Device: Anodal TDCS
  • Device: Cathodal TDCS
  • Device: Magnetic Resonance Imaging (MRI)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Towards More Successful Clinical Trials: Using a Patient-tailored Approach in Brain Stimulation to Improve Recovery of Movements After Stroke
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in movement time (seconds) for reaching after 1 session of TDCS [1 day]

  2. Change in accuracy of reaching (root mean square error) after 1 session of TDCS [1 day]

  3. Change in efficiency of reaching (number of velocity peaks) after 1 session of TDCS [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

Sponsors and Collaborators

  • Sunnybrook Health Sciences Centre

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT02473549
Other Study ID Numbers:
  • 143-2015
First Posted:
Jun 16, 2015
Last Update Posted:
Jun 3, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sunnybrook Health Sciences Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2022