Investigating the Feasibility of Combining Virtual Reality and Bilateral Transcranial Direct Stimulation to Improve Upper Limb Recovery in Patients With Stroke (bi-tDCS+VR)

King Saud University

Status: Enrolling

Conditions: Stroke; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases; Paresis

Treatments: Device: Transcranial Direct Current Stimulation combined with virtual reality; Other: Sham Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT07288385

IRB NO- 25-390 (Other Identifier)

IRB NO-25-390 KFMC

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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).

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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.

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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

bi-tDCS+VR

Experimental group

Description:

20 minutes of tDCS during 45 minutes of VR games.

Treatment:

Device: Transcranial Direct Current Stimulation combined with virtual reality

tDCS+ VR 20 minutes of sham tDCS combined with 45 minutes of VR

Sham Comparator group

Treatment:

Other: Sham Comparator