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

NCT ID: NCT02473549

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2021-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brain Stimulation

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

Group Type: EXPERIMENTAL

Sham TDCS

Intervention Type: DEVICE

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

Anodal TDCS

Intervention Type: DEVICE

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

Cathodal TDCS

Intervention Type: DEVICE

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

Magnetic Resonance Imaging (MRI)

Intervention Type: 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.

Interventions

Sham TDCS

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

Intervention Type: DEVICE

Anodal TDCS

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

Intervention Type: DEVICE

Cathodal TDCS

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

Intervention Type: 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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joyce Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Research Institute

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

143-2015

Identifier Type: -

Identifier Source: org_study_id