Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06786000

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

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

This clinical trial aims to evaluate the effect of different types of tDCS modulation with mCIMT in improving affected upper-limb motor function for stroke patients. The main question it seeks to answer: Which type of tDCS (bi-hemispheric, anodal, or cathodal) combined with the mCIMT program leads to greater improvement in affected upper-limb function in patients with stroke? Researchers will compare these three types of tDCS to a sham tDCS. To see which kind of tDCS protocol combined with the mCIMT program will be more effective in improving affected upper-limb function for stroke patients. Participants will: 1. Participants will receive 12 sessions of mCIMT combined with tDCS or mCIMT alone. 2. Visit the clinic three times a week for four weeks. 3. Participants will do fMRI and TMS before and after the program and three times of assessment before and after two weeks after the program.

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

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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

CONTACT

A

Ahmad O. Alokaily, PhD

CONTACT

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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