Combining virtual reality and brain stimulation to improve hand function after stroke
Investigating the Efficacy of Combining Virtual Reality-Based Mirror Therapy and Transcranial Direct Current Stimulation to Improve Upper Limb Recovery in Patients with Stroke
This study is testing if using virtual reality and brain stimulation together can help stroke patients improve their hand function better than just regular therapy alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King Saud University Academic / other |
| Locations | 2 sites (Riyadh, Riyadh Region and 1 other locations) |
| Trial ID | NCT06764797 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining virtual reality-based mirror therapy (VRMT) and transcranial direct current stimulation (tDCS) with conventional physical therapy (CPT) to enhance upper limb recovery in stroke patients. Participants will be randomly assigned to one of four groups to assess the impact of these interventions on hand function. The study aims to determine if the combination of VRMT and tDCS provides greater benefits than using either intervention alone. Functional scales will be utilized to evaluate improvements before and after the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced a stroke with moderate-to-severe arm impairment more than three months prior.
Not a fit: Patients with visual impairments, severe cognitive difficulties, or other neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance hand function and independence for stroke survivors.
How similar studies have performed: While the individual components of VRMT and tDCS have been explored, the combination approach in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years old. * Stroke patients with unilateral cerebral infarction or hemorrhage, more than three months following the stroke. * Adequate cognitive ability to follow instructions (The Arabic version of the Mini-Mental State Examination scores \> 24). * Modified Ashworth scale score \< 3. * Fugl-Meyer Assessment (FMA) score of 10-58 indicating moderate-to-severe arm impairment. Exclusion Criteria: * visual impairment and field defect or hemi-sensory inattention and unilateral neglect. * Wernicke's aphasia, or global aphasia, leads to difficulty following instructions. * Any contraindication to NIBS. * Other neurological conditions or participation in another study.
Where this trial is running
Riyadh, Riyadh Region and 1 other locations
- King fahad medical city — Riyadh, Riyadh Region, Saudi Arabia (Recruiting)
- King Khalid University Hospital — Riyadh, Riyadh Region, Saudi Arabia (Recruiting)
Study contacts
- Principal investigator: Alaa M. Albishi, Doctor of Philosophy — King Saud University
- Study coordinator: Dr. Alaa M. Albishi, Assistant Professor
- 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.