RecruitingNot ApplicableNCT07288385

Investigating the Feasibility of Combining Virtual Reality and Bilateral Transcranial Direct Stimulation to Improve Upper Limb Recovery in Patients With Stroke


Sponsor

King Saud University

Enrollment

100 participants

Start Date

Dec 28, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • Patients with a unilateral cerebral infarction or haemorrhage who are at least three months post-stroke (Muller et al., 2021).
  • Adequate mental status confirmed by an MMSE (Arabic version) should be ≥24 (Kim, 2021). ensuring the ability to comprehend and follow instructions.
  • 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 Criteria4

  • Individuals who have aphasia find it difficult to follow instructions (Fluet et al., 2015).
  • Presence of any medical condition that contraindicates the use of non-invasive brain stimulation (Stahl et al., 2019; Learmonth et al., 2021).
  • History of neurological disorders unrelated to stroke or participation in another study.
  • \-

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Interventions

DEVICETranscranial Direct Current Stimulation combined with virtual reality

20 minutes of tDCS during 45 minutes of VR games. bi-tDCS will be used during the sessions. The anodal tDCS (2 mA) will be applied for 20 minutes. Continuous, direct currents. The anodal electrode will be positioned over the ipsilesional primary motor cortex (M1) of the affected hemisphere and the cathodal electrode over the contralesional hemisphere.

OTHERSham Comparator

45 minutes of VR games with sham tDCS. This provides the participants with the experience of the initial itchy sensation that occurs during tDCS, which is required for efficient masking.


Locations(1)

King Fahad Medical City مدينه الملك فهد الطبيه, 6496 Makkah Al Mukarrama Road, الرياض, الرياض 12231

Riyadh, Saudi Arabia

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NCT07288385


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