Combining brain stimulation with movement therapy to improve arm function after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effects of different types of transcranial direct current stimulation (tDCS) when combined with modified-constraint induced movement therapy (mCIMT) on upper-limb motor function in stroke patients. Participants will be randomly assigned to receive either anodal, cathodal, or bihemispheric tDCS along with mCIMT, or mCIMT alone, over 12 sessions. The study will assess motor recovery through fMRI and TMS before and after the intervention, aiming to determine which tDCS modulation is most effective in enhancing rehabilitation outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult participants clinically diagnosed and confirmed by imaging of ischemic or hemorrhagic cerebrovascular accident (Dahl et al., 2008; Jin et al., 2019).
2. Participant's age older than 18 years (Baltar et al., 2020).
3. Stroke onset more than 3 months with unilateral motor deficits (Lin et al., 2010).
4. Adequate cognitive function is required to follow instructions. The Arabic version of the Mini Mental State Examination (MMSE) should be ≥24 (Kim, 2021).
5. 10° of active extension to the metacarpophalangeal and interphalangeal joints and 20° at wrist will be assessed by manual goniometer (Dahl et al., 2008).
6. Fugl-Meyer assessment (FMA) scores between 19 and 58, indicating moderate to mild impairments.
7. Not participating in other clinical, or research studies at the same time.

Exclusion Criteria:

1. Severe muscle spasticity at the affected limb at all joints (the Modified Ashworth Scale scores \> 3) (Baltar et al., 2020).
2. Contraindications to NIBS (Bornheim et al., 2019).
3. Unilateral neglect (Dahl et al., 2008)
4. Other neurologic or orthopedic conditions that may affect hand function.
5. Unstable medical conditions.

Where it's running

• King Saud University Medical City
  Riyadh, Riyadh Region, Saudi Arabia Recruiting

Study contacts

• Study coordinator: Alaa M. Albishi, PhD in Rehabilitation Sciences
• Email: aalbeshi@KSU.EDU.SA
• Phone: +966555090015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.