Virtual reality plus bilateral brain stimulation to improve arm and hand recovery after stroke
Investigating the Feasibility of Combining Virtual Reality and Bilateral Transcranial Direct Stimulation to Improve Upper Limb Recovery in Patients With Stroke
We will try combining virtual reality exercises with bilateral transcranial direct current stimulation (bi‑tDCS) to improve arm and hand movement in adults at least three months after a unilateral stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King Saud University Academic / other |
| Locations | 1 site (Riyadh) |
| Trial ID | NCT07288385 on ClinicalTrials.gov |
What this trial studies
This interventional protocol pairs task-specific virtual reality training with simultaneous bilateral tDCS to promote motor learning and neural activation in the affected upper limb of chronic stroke survivors. Eligible participants meeting cognitive and motor thresholds (MMSE ≥24, FMA 29–58, Modified Ashworth <3) will be randomized to active bi‑tDCS plus VR or sham stimulation plus VR. Outcomes will focus on changes in upper limb motor function and hand dexterity measured before and after the intervention. The primary aim is to test feasibility and whether adding bi‑tDCS produces greater functional gains than VR with sham stimulation.
Who should consider this trial
Good fit: Adults at least three months after a unilateral ischemic or hemorrhagic stroke with moderate arm/hand impairment (FMA 29–58), minimal spasticity (Modified Ashworth <3), and sufficient cognition (MMSE ≥24) are ideal candidates.
Not a fit: People with severe cognitive problems, major visual or hemisensory neglect, significant aphasia, medical contraindications to noninvasive brain stimulation, or very mild or very severe motor deficits are unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could improve hand and finger function and increase independence in daily activities for people with moderate chronic post-stroke upper limb weakness.
How similar studies have performed: Previous trials pairing motor practice with tDCS and separate VR rehabilitation studies have shown promise for motor recovery, but the specific combination of bilateral tDCS with VR for upper limb recovery is relatively novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1- Adult participants (over 18 years of age) (Elsner et al., 2020). 2- Patients with a unilateral cerebral infarction or haemorrhage who are at least three months post-stroke (Muller et al., 2021). 3- Adequate mental status confirmed by an MMSE (Arabic version) should be ≥24 (Kim, 2021). ensuring the ability to comprehend and follow instructions. 4- Modified Ashworth scale score \< 3 (Ögün et al., 2019). 5- Fugl-Meyer assessment (FMA) scores between 29 and 58, indicating moderate impairments (Woytowicz et al., 2017). \- Exclusion Criteria: - Visual impairment and severe hemisensory neglect or inattention (Stahl et al., 2019; Fluet1 et al., 2015). 2- Individuals who have aphasia find it difficult to follow instructions (Fluet et al., 2015). 3- Presence of any medical condition that contraindicates the use of non-invasive brain stimulation (Stahl et al., 2019; Learmonth et al., 2021). 4- History of neurological disorders unrelated to stroke or participation in another study. \-
Where this trial is running
Riyadh
- King Fahad Medical City مدينه الملك فهد الطبيه, 6496 Makkah Al Mukarrama Road, الرياض, الرياض 12231 — Riyadh, Saudi Arabia (Recruiting)
Study contacts
- Study coordinator: Sarah Almhawas, PT
- Email: 446200649@student.ksu.edu.sa
- Phone: 0555677296
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.