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

NCT ID: NCT07288385

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-28
• Study Completion Date: 2027-01-30

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.

Conditions

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

Keywords

ischemic stroke; Hemorrhagic stroke; bi-tDCS; Hemiparesis; Neural activation; Primary motor cortex; NIBS; Non-invasive brain stimulation; Transcranial direct current stimulation; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

bi-tDCS+VR

20 minutes of tDCS during 45 minutes of VR games.

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation combined with virtual reality

Intervention Type: DEVICE

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.

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

Group Type: SHAM_COMPARATOR

Sham Comparator

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Saud Medical City

OTHER_GOV

Sponsor Role: collaborator

King Fahad Medical City

OTHER_GOV

Sponsor Role: collaborator

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Sarah Almhawas

PT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Riyadh, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Sarah Almhawas, PT

Role: CONTACT

Phone: 0555677296

Email: 446200649@student.ksu.edu.sa

Dr. Alaa M Albishi albishi, Associate Professor

Role: CONTACT

Phone: 0555090015

Email: aalbeshi@ksu.edu.sa

Facility Contacts

Dr Fahd Alsubaie, Phd

Role: primary

Other Identifiers

IRB NO- 25-390

Identifier Type: OTHER

Identifier Source: secondary_id

IRB NO-25-390 KFMC

Identifier Type: -

Identifier Source: org_study_id