Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06786000

Neurophysiological and Behavioral Effects of Combining Transcranial Direct Current Stimulation (tDCS) and Modified-Constraint Induced Movement Therapy (mCIMT) on Upper Limb Function Recovery in Patients with Stroke

Led by King Saud University · Updated on 2025-01-22

300

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

K

King Saud University

Lead Sponsor

K

King Saud Medical City

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of different types of transcranial direct current stimulation (tDCS) combined with modified constraint induced movement therapy (mCIMT) on improving upper limb motor function in patients who have experienced a stroke. The study aims to determine which type of tDCS—bi-hemispheric, anodal, or cathodal—along with mCIMT leads to the greatest improvement compared to a sham tDCS treatment. This trial focuses on adults who have had ischemic or hemorrhagic strokes with unilateral motor deficits and are cognitively able to follow instructions. Participants will be randomly assigned to one of four groups: anodal tDCS with mCIMT, cathodal tDCS with mCIMT, bi-hemispheric tDCS with mCIMT, or mCIMT alone with sham tDCS. Each session includes 20 minutes of the assigned tDCS type followed by one hour of mCIMT exercises involving twelve different tasks. The sessions are conducted three times a week over four weeks, totaling 12 treatment sessions. The tDCS electrodes are placed over specific brain areas depending on the assigned group to modulate cortical excitability. During the study, participants will undergo motor and physiological assessments at baseline, after two weeks, and after the full four-week intervention. Measurements include motor function tests such as the Fugl-Meyer Assessment, Wolf Motor Function Test, and Nine-Hole Peg Test. Brain activity and excitability will be evaluated using functional MRI and transcranial magnetic stimulation. Safety and adherence will be monitored throughout, with additional assessments of stroke impact and exercise adherence. The total participation spans the four-week intervention period with multiple evaluations.

CONDITIONS

Official Title

Neurophysiological and Behavioral Effects of Combining Transcranial Direct Current Stimulation (tDCS) and Modified-Constraint Induced Movement Therapy (mCIMT)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults clinically diagnosed with ischemic or hemorrhagic stroke confirmed by imaging
  • Age older than 18 years
  • Stroke onset more than 3 months ago with unilateral motor deficits
  • Adequate cognitive function with Arabic Mini Mental State Examination (MMSE) score of 24 or higher
  • At least 10 degrees of active extension at the metacarpophalangeal and interphalangeal joints and 20 degrees at the wrist
  • Fugl-Meyer Assessment scores between 19 and 58 indicating mild to moderate impairments
  • Not participating in other clinical or research studies at the same time
Not Eligible

You will not qualify if you...

  • Severe muscle spasticity at all affected joints with Modified Ashworth Scale score greater than 3
  • Contraindications to non-invasive brain stimulation
  • Presence of unilateral neglect
  • Other neurological or orthopedic conditions affecting hand function
  • Unstable medical conditions

AI-Screening

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Trial Site Locations

Total: 1 location

1

King Saud University Medical City

Riyadh, Riyadh Region, Saudi Arabia, 12372

Actively Recruiting

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Research Team

A

Alaa M. Albishi, PhD in Rehabilitation Sciences

A

Ahmad O. Alokaily, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Published Research Related To This Trial

Baseline Motor Impairment Predicts Transcranial Direct Current Stimulation Combined with Physical Therapy-Induced Improvement in Individuals with Chronic Stroke.

Adriana Baltar, Daniele Piscitelli, Déborah Marques...

https://pubmed.ncbi.nlm.nih.gov/33299400