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OpenTrials
Completed

NCT Number: NCT02473549

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sham tDCS

Device

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

Anodal tDCS

Device

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

Cathodal tDCS

Device

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

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.

Primary outcomes

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

    Time frame: 1 day

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

    Time frame: 1 day

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

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2015
Registry last updated
Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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