Combining brain stimulation with movement therapy to improve arm function after stroke
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
This study is testing whether adding different types of brain stimulation to movement therapy can help stroke patients improve their arm function better than movement therapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King Saud University Academic / other |
| Locations | 1 site (Riyadh, Riyadh Region) |
| Trial ID | NCT06786000 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have experienced a stroke more than three months prior and have unilateral motor deficits.
Not a fit: Patients with severe muscle spasticity or contraindications to non-invasive brain stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve upper-limb recovery in stroke patients, enhancing their quality of life.
How similar studies have performed: Previous studies have shown promising results in combining tDCS with rehabilitation therapies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Riyadh, Riyadh Region
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.