Investigating the Feasibility of Combining Virtual Reality and Bilateral Transcranial Direct Stimulation to Improve Upper Limb Recovery in Patients With Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Direct Current Stimulation combined with virtual reality, Sham Comparator.
- Who it may be relevant to
- Registry conditions: Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Transcranial 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. - Other Sham 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.
Primary outcome measures
- Wolf Motor Function Test (WMFT) [Time frame: at baseline and after intervention (4 weeks).]
- Fugl-Meyer Assessment Scale Upper Extremity (FMA-UE): [Time frame: at baseline and after intervention (4 weeks).]
- Box and Block Test (BBT): [Time frame: at baseline and after intervention (4 weeks).]
- Cortical Excitability Assessment: [Time frame: at baseline and after intervention (4 weeks).]
- Functional magnetic resonance imaging (fMRI): [Time frame: at baseline and after intervention (4 weeks).]
Secondary outcome measures (2)
- The Arabic version of the Stroke Specific Quality of Life Scale (SS-QOL): [Time frame: at baseline and after intervention (4 weeks).]
- Arabic Version of Stroke Impact Scale (SIS-16): [Time frame: at baseline and after intervention (4 weeks).]
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.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Saudi Arabia · 1 center
- King Fahad Medical City مدينه الملك فهد الطبيه, 6496 Makkah Al Mukarrama Road, الرياض, الر — Riyadh
Identifiers
NCT: NCT07288385 · IRB NO-25-390 KFMC · IRB NO- 25-390