Brain Diseasesbi-tDCS+VRNCT07288385
Investigating the Feasibility of Combining Virtual Reality and Bilateral Transcranial Direct Stimulation to Improve Upper Limb Recovery in Patients With Stroke
A study testing Transcranial Direct Current Stimulation combined with virtual reality in people with Brain Diseases and Central Nervous System Diseases, run by King Saud University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- What is being tested?
- Transcranial Direct Current Stimulation combined with virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 28 Dec 2025to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Fahad Medical City مدينه الملك فهد الطبيه, 6496 Makkah Al Mukarrama Road, الرياض, الرياض 12231
Riyadh
Dr Fahd Alsubaie, Phd, 0554728899, falsubaie@kfmc.med.sa
About this study
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.
- Being tested
- Transcranial Direct Current Stimulation combined with virtual reality, Sham Comparator
- Keywords
- ischemic stroke, Hemorrhagic stroke, bi-tDCS, Hemiparesis, Neural activation, Primary motor cortex, NIBS, Non-invasive brain stimulation, Transcranial direct current stimulation, Stroke
- Medical subject headings
- Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Stroke, Paresis, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation combined with virtual realityDevice
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 ComparatorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| bi-tDCS+VR | Experimental | 20 minutes of tDCS during 45 minutes of VR games. Receives: Device: Transcranial Direct Current Stimulation combined with virtual reality |
| tDCS+ VR 20 minutes of sham tDCS combined with 45 minutes of VR | Sham comparator | Not described Receives: Other: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: at baseline and after intervention (4 weeks).
Secondary outcomes (2)
The Arabic version of the Stroke Specific Quality of Life Scale (SS-QOL):
The Stroke Specific Quality of Life Scale (SS-QOL) is a self-report questionnaire designed to assess quality of life. The 49 items on the SS-QOL measure are divided into 12 domains, which include family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision, energy, and work/productivity. Each of the 49 items is evaluated on a consistent five-point scale. Each item's responses are summed up, and the composite score that results varies from a minimum of 49 to a maximum of 245; higher scores indicate a better quality of life. The SS-QOL-49 has been translated into Arabic, and it has good validity and reliability for patients with stroke (Sallam et al., 2019).
Measured: at baseline and after intervention (4 weeks).
Arabic Version of Stroke Impact Scale (SIS-16):
The Stroke Impact Scale (SIS) is a specific self-report measure used to assess health status in individuals after a stroke. It includes 16 items that assess different aspects of daily functioning: 7 items cover basic and instrumental activities of daily living, 8 items focus on mobility, and 1 item evaluates hand function. Each item is rated on a 5-point Likert scale, ranging from 1 (unable to complete) to 5 (no difficulty at all) (P. Duncan et al., 2003; P. W. Duncan et al., 2003). Higher scores reflect a better health-related quality of life among patients with stroke (P. W. Duncan et al., 2003). The SIS-16 is a valid and reliable tool for evaluating quality of life in patients with stroke (Chou et al., 2015).
Measured: at baseline and after intervention (4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start28 Dec 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Collaborators
- King Saud Medical City, King Fahad Medical City
- Responsible party
- Principal investigator, Sarah Almhawas, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288385
- Sponsor's protocol ID
- IRB NO-25-390 KFMC
- Other IDs
- IRB NO- 25-390
- Acronym
- bi-tDCS+VR
- Status last verified
- Nov 2025
- First submitted
- 4 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Feasibility of Combining Virtual Reality and Bilateral Transcranial Direct Stimulation to Improve Upper Limb Recovery in Patients With Stroke
- ClinicalTrials.gov ID
- NCT07288385
- Acronym / sponsor ID
- bi-tDCS+VR / IRB NO-25-390 KFMC
- Keywords
- ischemic stroke, Hemorrhagic stroke, bi-tDCS, Hemiparesis, Neural activation, Primary motor cortex, NIBS, Non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Collaborators
- King Saud Medical City, King Fahad Medical City
- Study start
- 28 Dec 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| bi-tDCS+VR | Experimental | Device: Transcranial Direct Current Stimulation combined with virtual reality20 minutes of tDCS during 45 minutes of VR games. |
| tDCS+ VR 20 minutes of sham tDCS combined with 45 minutes of VR | Sham comparator | Other: Sham Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation combined with virtual reality20 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. | Device | bi-tDCS+VR |
| Sham Comparator45 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. | Other | tDCS+ VR 20 minutes of sham tDCS combined with 45 minutes of VR |
Primary outcome
Wolf Motor Function Test (WMFT)
Time frame: at baseline and after intervention (4 weeks).
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.
Fugl-Meyer Assessment Scale Upper Extremity (FMA-UE):
Time frame: at baseline and after intervention (4 weeks).
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.
Box and Block Test (BBT):
Time frame: at baseline and after intervention (4 weeks).
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.
Cortical Excitability Assessment:
Time frame: at baseline and after intervention (4 weeks).
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)
Functional magnetic resonance imaging (fMRI):
Time frame: at baseline and after intervention (4 weeks).
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).
2 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation combined with virtual reality in people with Brain Diseases and Central Nervous System Diseases, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Almhawas, PT (0555677296, 446200649@student.ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test (WMFT) (time frame: at baseline and after intervention (4 weeks).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.