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

NCT02473549 | Completed DMC

• 1 other identifier: 143-2015
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

motor; rehabilitation; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (3)

• Change in movement time (seconds) for reaching after 1 session of TDCS

  1 day

• Change in accuracy of reaching (root mean square error) after 1 session of TDCS

  1 day

• Change in efficiency of reaching (number of velocity peaks) after 1 session of TDCS

  1 day

Study Arms (1)

Brain Stimulation

EXPERIMENTAL

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

Device: Sham TDCS; Device: Anodal TDCS; Device: Cathodal TDCS; Device: Magnetic Resonance Imaging (MRI)

Interventions

Sham TDCS DEVICE

Placebo stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity

Brain Stimulation

Anodal TDCS DEVICE

Excitatory stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity

Brain Stimulation

Cathodal TDCS DEVICE

Inhibitory stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity

Brain Stimulation

Magnetic Resonance Imaging (MRI) DEVICE

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.

Brain Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Joyce Chen, PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2015
• First Posted: June 16, 2015
• Study Start: September 1, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 3, 2022

Record last verified: 2022-06

Locations

CA (1)