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

NCT07288385 | Recruiting

• 2 other identifiers: IRB NO-25-390 KFMCIRB NO- 25-390
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Wolf Motor Function Test (WMFT)

  The WMFT is a standardized assessment used to measure upper extremity motor ability through the performance of 17 tasks that include both functional and strength components. Rated using the 6-point scale ranging from 0 (no attempt) to 5 (normal movement). The total performance time and quality of movement are recorded, with lower scores indicating lower levels of functioning.

  at baseline and after intervention (4 weeks).

• Fugl-Meyer Assessment Scale Upper Extremity (FMA-UE):

  The FMA-UE is a comprehensive quantitative measure designed to evaluate motor function, coordination, and reflex activity of the affected upper limb following stroke. It uses a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), with a maximum score of 66 points for the upper extremity. It is considered the gold standard for assessment of upper limb motor recovery.

  at baseline and after intervention (4 weeks).

• Box and Block Test (BBT):

  The BBT is a validated measure of gross manual dexterity that evaluates how many 1-inch wooden blocks a participant can transfer from one compartment to another within 60 seconds using one hand. The apparatus consists of a wooden box divided into two equal sections containing 150 small cubes. The test begins with the unaffected upper limb to allow practice and establish a baseline performance. Participants are then instructed to move as many blocks as possible, one at a time, over the partition within the time limit. The score is defined as the total number of blocks successfully transferred within 60 seconds.

  at baseline and after intervention (4 weeks).

• Cortical Excitability Assessment:

  Corticospinal excitability will be evaluated using transcranial magnetic stimulation (TMS) to measure motor evoked potentials (MEPs) elicited by TMS in both the affected and unaffected motor cortices (Wassermann et al., 2008). Electromyographic (EMG) activity will be monitored in real-time during TMS application, with MEPs recorded bilaterally from the first dorsal interosseous (FDI)

  at baseline and after intervention (4 weeks).

• Functional magnetic resonance imaging (fMRI):

  Functional magnetic resonance imaging (fMRI), a specialized form of MRI, will be utilized to assess brain activity and neural connectivity. The fMRI protocol will employ a block design paradigm, with each scanning session lasting 6 minutes and divided into six blocks. Each block will consist of 15 repetitions of 2-second contractions, separated by 30-second rest intervals (Wen et al., 2014). During the task, participants will be instructed to squeeze a rubber ball with their affected hand at an intensity corresponding to 30% of their maximum voluntary contraction force (Cheng et al., 2021; Ismail et al., 2014). Visual cues will be displayed to assist participants in achieving the target force level (Könönen et al., 2012).

  at baseline and after intervention (4 weeks).

Secondary Outcomes (2)

• The Arabic version of the Stroke Specific Quality of Life Scale (SS-QOL):

  at baseline and after intervention (4 weeks).

• Arabic Version of Stroke Impact Scale (SIS-16):

  at baseline and after intervention (4 weeks).

Study Arms (2)

bi-tDCS+VR

EXPERIMENTAL

20 minutes of tDCS during 45 minutes of VR games.

Device: Transcranial Direct Current Stimulation combined with virtual reality

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

SHAM COMPARATOR

Other: Sham Comparator

Interventions

Sham Comparator 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.

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

Transcranial Direct Current Stimulation combined with virtual reality 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.

bi-tDCS+VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead
• King Saud Medical City: collaborator
• King Fahad Medical City: collaborator

Study Sites (1)

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

Riyadh, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sarah Almhawas, PT

CONTACT

0555677296; 446200649@student.ksu.edu.sa

Dr. Alaa M Albishi albishi, Associate Professor

CONTACT

0555090015; aalbeshi@ksu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT

Model Details: Experimental: Bi-tDCS combined with VR 20 minutes of Bi-tDCS combined with 45 minutes of VR 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. Sham Comparator: tDCS+ VR 20 minutes of sham tDCS combined with 45 minutes of VR 45 minutes of VR games with sham tDCS

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: December 28, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-11

Locations

SA (1)