NCT07288385 Investigating the Feasibility of Combining Virtual Reality and Bilateral Transcranial Direct Stimulation to Improve Upper Limb Recovery in Patients With Stroke
| NCT ID | NCT07288385 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King Saud University |
| Condition | Brain Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-12-28 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-12-28 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Following a stroke, the function of the distal upper limb, especially hand and finger movements, is often severely compromised, significantly restricting the ability to carry out daily activities. It is estimated that 55-75% of stroke survivors suffer from motor dysfunction, with upper limb impairments affecting up to 85% of them (Tang et al., 2024). Current rehabilitation approaches, while beneficial, often produce limited gains in hand function, particularly in patients with chronic stroke. Virtual reality (VR) training has emerged as a promising tool in neurorehabilitation, providing repetitive, task-specific, and engaging practice environments that can promote motor learning (Cameirão et al., 2012). tDCS has also shown potential to enhance motor recovery when combined with motor practice (Kang et al., 2016). To date, no studies have directly compared the effectiveness of Bi-tDCS with VR for improving upper limb function after stroke.
Eligibility 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. \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07288385 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07288385 currently recruiting?
Yes, NCT07288385 is actively recruiting participants. Contact the research team at 446200649@student.ksu.edu.sa for enrollment information.
Where is the NCT07288385 trial being conducted?
This trial is being conducted at Riyadh, Saudi Arabia.
Who is sponsoring the NCT07288385 clinical trial?
NCT07288385 is sponsored by King Saud University. The trial plans to enroll 100 participants.