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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473549
• Other study ID #: 143-2015
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Sham TDCS
Placebo stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity
• Anodal TDCS
Excitatory stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity
• Cathodal TDCS
Inhibitory stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity
• 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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in movement time (seconds) for reaching after 1 session of TDCS		1 day
Primary	Change in accuracy of reaching (root mean square error) after 1 session of TDCS		1 day
Primary	Change in efficiency of reaching (number of velocity peaks) after 1 session of TDCS		1 day