Stroke RehabilitaionPhase 3tDCSNCT06764797
Investigating the Efficacy of Combining Virtual Reality-Based Mirror Therapy (VRMT) and Transcranial Direct Current Stimulation (tDCS) to Improve Upper Limb Recovery in Patients with Stroke
A Phase 3 study testing Transcranial Direct Current Stimulation, Virtual reality and Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy in people with Stroke Rehabilitaion and Stroke, run by King Saud University at 2 sites in Saudi Arabia.
Trial summary
This study will investigate whether combining virtual reality-based mirror therapy (VRMT) and transcranial direct current stimulation (tDCS) alongside conventional physical therapy (CPT) will significantly improve hand function for patients with stroke compared to using VRMT or tDCS alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Rehabilitaion, Stroke
- What is being tested?
- Transcranial Direct Current Stimulation, Virtual reality and Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 19 Sep 2023to 21 Jul 2025
- Phase
- Phase 3
- 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
Who may be able to join
- At least 18 years old.
- Stroke patients with unilateral cerebral infarction or hemorrhage, more than three months following the stroke.
- Adequate cognitive ability to follow instructions (The Arabic version of the Mini-Mental State Examination scores > 24).
- Modified Ashworth scale score < 3.
- Fugl-Meyer Assessment (FMA) score of 10-58 indicating moderate-to-severe arm impairment.
Who cannot join
- visual impairment and field defect or hemi-sensory inattention and unilateral neglect.
- Wernicke's aphasia, or global aphasia, leads to difficulty following instructions.
- Any contraindication to NIBS.
- Other neurological conditions or participation in another study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia2 sites, 2 recruiting
- Recruiting
King fahad medical city
Riyadh, Riyadh Region, 11461
Dr. Fahad alsubaie alsubaie, Phd, +966554728899, falsubaie@kfmc.med.sa
- Recruiting
King Khalid University Hospital
Riyadh, Riyadh Region, 11461
Dr. Taha Inam Dr. Taha Inam, Phd, +966548083373, dr_taha_inam@hotmail.com
About this study
Official title: Investigating the Efficacy of Combining Virtual Reality-Based Mirror Therapy and Transcranial Direct Current Stimulation to Improve Upper Limb Recovery in Patients with Stroke
This study will investigate whether combining virtual reality-based mirror therapy (VRMT) and transcranial direct current stimulation (tDCS) alongside conventional physical therapy (CPT) will significantly improve hand function for patients with stroke compared to using VRMT or tDCS alone.
Read the detailed description
More than half of stroke survivors suffer from upper-limb dysfunction that persists years after stroke, negatively impacting patients' independence and, therefore, affecting their quality of life. Motor rehabilitation is required after a stroke to facilitate motor recovery. More importantly, finding new ways to maximize patients' motor recovery is a core goal of stroke rehabilitation. Thus, researchers have explored the potential benefits of using advanced technologies such as virtual reality-based mirror therapy (VRMT) and transcranial direct current stimulation (tDCS) to boost the brain's responses to interventions and maximize the effects of rehabilitation to improve upper-limb recovery post-stroke. However, the potential impact of combining VRMT and tDCS on upper limb functions for patients with stroke has not been explored. Therefore, the goal of this study is to investigate whether combining virtual reality-based mirror therapy (VRMT) with transcranial direct current stimulation (tDCS) alongside conventional physical therapy (CPT) will significantly improve hand function for patients with stroke compared to using VRMT or tDCS alone.
The participants will be randomly assigned into one of the four groups: (1) the anodal tDCS + VRMT group, (2) the anodal tDCS alone group, (3) the VRMT alone with sham tDCS group, and (4) the CPT with sham tDCS group. All groups will receive CPT as part of the treatment. Functional scales will be used before and after the intervention to assess upper motor functions. These measures include the Fugl-Meyer Assessment, Wolf Motor Function Test, Box and Block Test, Nine-Hole Pegboard Test, and Stroke Impact Scale-16 (SIS-16). In addition, physiological measures such as transcranial magnetic stimulation (TMS) and task-based fMRI.
- Conditions
- Stroke Rehabilitaion, Stroke
- Being tested
- Transcranial Direct Current Stimulation, Virtual reality, Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy, Conventional physical therapy
- Keywords
- Virtual reality, Mirror therapy, non invasive brain stimulation, tDCS, stroke, transcranial direct current stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
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) (C3 or C4, international 10-20 system) of the affected hemisphere and the cathodal electrode over the contralateral orbit.
Virtual realityDevice
The VRMT group will receive VRMT game-based training using their non-affected upper limb. using a semi-immersive motion-tracking device.
Transcranial Direct Current Stimulation compined with virtual reality based mirror therapyDevice
20 minutes of tDCS during 45 minutes of VRMT games.
Conventional physical therapyOther
45 minutes of conventional physical therapy with sham tDCS
| Study group | Role | What they receive |
|---|---|---|
| anodal tDCS combined with VRMT | Experimental | 20 minutes of anodal tDCS combined with 45 minutes of VRMT Receives: Device: Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy |
| Anodal tDCS alone | Active comparator | 20 minutes of anodal tDCS alone Receives: Device: Transcranial Direct Current Stimulation |
| VRMT alone, Sham tDCS | Active comparator | 45 minutes of VRMT alone, For the sham-tDCS, the current flow will be terminated after 30 seconds. Receives: Device: Virtual reality |
| Conventional Physical therapy alone, Sham tDCS | Sham comparator | 45 minutes of conventional physical therapy, For the sham-tDCS, the current flow will be terminated after 30 seconds. Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Mayer Upper limb assessment (FMA)
FMA is a performance-based impairment measure particular to strokes, designed to assess motor functioning, balance, sensory, and joint functionality. It consists of five domains, which have 155 total items. The full potential scale score is 226. Scale items are scored based on the ability to finish the item using a 3-point ordinal scale. Motor score: from 0 to 100, 66 points for the upper extremity and 34 points for the lower extremities.
Measured: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
Wolf motor function test (WMT)
WMT, consisting of timed and practical tasks, measures the motor function of the upper extremity (UE). The WMFT has 17 items in the most common version. The first six items involved timed functional tasks; items 7 and 14 were strength tests, and the final nine analyzed the participants' movement quality while carrying out various tasks. Items scored on a 6-point scale, with lower scores indicating lower levels of functioning.
Measured: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
box and blocks test (BBT)
BBT assesses manual dexterity of the hand. It requires subjects to lift and release 2.5 cm³ cubes to move them from one compartment to another. BBT comprises 150 blocks. The test should begin with the unaffected upper limb to practice and record baseline values. The score is defined as the number of blocks transferred correctly within 60 seconds.
Measured: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
Nine-Hole Peg Test (NHPT)
NHPT was developed to assess finger dexterity. It is made up of a nine-peg square board. The board has holes on one end for the pegs to fit into, and it also has a shallow circular dish on the other for storing the pegs. The patient is instructed to quickly insert the pegs into the holes on the board after taking each one out of a container as part of the NHPT. Then, one by one, clients must bring the pegs out of the holes and put them back into the container. Scoring is according to how long it took them to finish the test activity, measured in seconds.
Measured: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
Secondary outcomes (3)
Stroke impact scale-16 (SIS-16)
SIS is a self-report health status measure specific to the stroke population. It consists of 16 items from the four physical domains (strength, hand function ADL/IADL, and mobility).
Measured: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
transcranial magnetic stimulation (TMS)
TMS measures cortical excitability, which is non-invasive magnetic stimulation using brief-duration, fast-pulsating, or pulsed magnetic fields to induce electrical currents targeted at spatially separate parts of the cerebral cortex using a computerized, electromechanical medical device.
Measured: at baseline, and after intervention ( 4 weeks).
Functional magnetic resonance imaging (fMRI)
fMRI technique uses MRI technology to evaluate brain activity by looking for variations in blood flow. The coupling between cerebral blood flow and neuronal activation is the basis for this method. The participants will be trained on the task before the experimental session. A block design will be used in the fMRI scan; each fMRI scan lasts for 6 minutes, divided into six blocks with an interval of 30 seconds of task, 15 repeated contractions, each contraction lasting 2 seconds, interspersed with 30 seconds of rest.
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 posted8 Jan 2025
- Study start19 Sep 2023
- Primary completion31 May 2025 (estimated)
- Study completion21 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke RehabilitaionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Collaborators
- King Fahad Medical City, King Saud Medical City
- Responsible party
- Principal investigator, Dr. Alaa Albishi, King Saud University
- Investigators
- Alaa M. Albishi, Doctor of Philosophy, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764797
- Sponsor's protocol ID
- E-23-7496
- Other IDs
- Not funded
- Acronym
- tDCS
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Combining Virtual Reality-Based Mirror Therapy and Transcranial Direct Current Stimulation to Improve Upper Limb Recovery in Patients with Stroke
- ClinicalTrials.gov ID
- NCT06764797
- Acronym / sponsor ID
- tDCS / E-23-7496
- Conditions
- Stroke Rehabilitaion, Stroke
- Keywords
- Virtual reality, Mirror therapy, non invasive brain stimulation, tDCS, stroke, transcranial direct current stimulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Collaborators
- King Fahad Medical City, King Saud Medical City
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 21 Jul 2025 (estimated)
- First posted
- 8 Jan 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.
This study will investigate whether combining virtual reality-based mirror therapy (VRMT) and transcranial direct current stimulation (tDCS) alongside conventional physical therapy (CPT) will significantly improve hand function for patients with stroke compared to using VRMT or tDCS alone.
Detailed description
More than half of stroke survivors suffer from upper-limb dysfunction that persists years after stroke, negatively impacting patients' independence and, therefore, affecting their quality of life. Motor rehabilitation is required after a stroke to facilitate motor recovery. More importantly, finding new ways to maximize patients' motor recovery is a core goal of stroke rehabilitation. Thus, researchers have explored the potential benefits of using advanced technologies such as virtual reality-based mirror therapy (VRMT) and transcranial direct current stimulation (tDCS) to boost the brain's responses to interventions and maximize the effects of rehabilitation to improve upper-limb recovery post-stroke. However, the potential impact of combining VRMT and tDCS on upper limb functions for patients with stroke has not been explored. Therefore, the goal of this study is to investigate whether combining virtual reality-based mirror therapy (VRMT) with transcranial direct current stimulation (tDCS) alongside conventional physical therapy (CPT) will significantly improve hand function for patients with stroke compared to using VRMT or tDCS alone.
The participants will be randomly assigned into one of the four groups: (1) the anodal tDCS + VRMT group, (2) the anodal tDCS alone group, (3) the VRMT alone with sham tDCS group, and (4) the CPT with sham tDCS group. All groups will receive CPT as part of the treatment. Functional scales will be used before and after the intervention to assess upper motor functions. These measures include the Fugl-Meyer Assessment, Wolf Motor Function Test, Box and Block Test, Nine-Hole Pegboard Test, and Stroke Impact Scale-16 (SIS-16). In addition, physiological measures such as transcranial magnetic stimulation (TMS) and task-based fMRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| anodal tDCS combined with VRMT | Experimental | Device: Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy20 minutes of anodal tDCS combined with 45 minutes of VRMT |
| Anodal tDCS alone | Active comparator | Device: Transcranial Direct Current Stimulation20 minutes of anodal tDCS alone |
| VRMT alone, Sham tDCS | Active comparator | Device: Virtual reality45 minutes of VRMT alone, For the sham-tDCS, the current flow will be terminated after 30 seconds. |
| Conventional Physical therapy alone, Sham tDCS | Sham comparator | Other: Conventional physical therapy45 minutes of conventional physical therapy, For the sham-tDCS, the current flow will be terminated after 30 seconds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old.
- Stroke patients with unilateral cerebral infarction or hemorrhage, more than three months following the stroke.
- Adequate cognitive ability to follow instructions (The Arabic version of the Mini-Mental State Examination scores > 24).
- Modified Ashworth scale score < 3.
- Fugl-Meyer Assessment (FMA) score of 10-58 indicating moderate-to-severe arm impairment.
Key exclusion criteria (4 listed)
- visual impairment and field defect or hemi-sensory inattention and unilateral neglect.
- Wernicke's aphasia, or global aphasia, leads to difficulty following instructions.
- Any contraindication to NIBS.
- Other neurological conditions or participation in another study.
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 StimulationtDCS 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) (C3 or C4, international 10-20 system) of the affected hemisphere and the cathodal electrode over the contralateral orbit. | Device | Anodal tDCS alone |
| Virtual realityThe VRMT group will receive VRMT game-based training using their non-affected upper limb. using a semi-immersive motion-tracking device. | Device | VRMT alone, Sham tDCS |
| Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy20 minutes of tDCS during 45 minutes of VRMT games. | Device | anodal tDCS combined with VRMT |
| Conventional physical therapy45 minutes of conventional physical therapy with sham tDCS | Other | Conventional Physical therapy alone, Sham tDCS |
Primary outcome
Fugl-Mayer Upper limb assessment (FMA)
Time frame: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
FMA is a performance-based impairment measure particular to strokes, designed to assess motor functioning, balance, sensory, and joint functionality. It consists of five domains, which have 155 total items. The full potential scale score is 226. Scale items are scored based on the ability to finish the item using a 3-point ordinal scale. Motor score: from 0 to 100, 66 points for the upper extremity and 34 points for the lower extremities.
Wolf motor function test (WMT)
Time frame: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
WMT, consisting of timed and practical tasks, measures the motor function of the upper extremity (UE). The WMFT has 17 items in the most common version. The first six items involved timed functional tasks; items 7 and 14 were strength tests, and the final nine analyzed the participants' movement quality while carrying out various tasks. Items scored on a 6-point scale, with lower scores indicating lower levels of functioning.
box and blocks test (BBT)
Time frame: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
BBT assesses manual dexterity of the hand. It requires subjects to lift and release 2.5 cm³ cubes to move them from one compartment to another. BBT comprises 150 blocks. The test should begin with the unaffected upper limb to practice and record baseline values. The score is defined as the number of blocks transferred correctly within 60 seconds.
Nine-Hole Peg Test (NHPT)
Time frame: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
NHPT was developed to assess finger dexterity. It is made up of a nine-peg square board. The board has holes on one end for the pegs to fit into, and it also has a shallow circular dish on the other for storing the pegs. The patient is instructed to quickly insert the pegs into the holes on the board after taking each one out of a container as part of the NHPT. Then, one by one, clients must bring the pegs out of the holes and put them back into the container. Scoring is according to how long it took them to finish the test activity, measured in seconds.
3 secondary outcomes
Stroke impact scale-16 (SIS-16)
Time frame: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
transcranial magnetic stimulation (TMS)
Time frame: at baseline, and after intervention ( 4 weeks).
Functional magnetic resonance imaging (fMRI)
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 8 Jan 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.
Alaa M. Albishi, Doctor of Philosophy principal investigator
King Saud University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transcranial Direct Current Stimulation, Virtual reality and Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy in people with Stroke Rehabilitaion and Stroke, run by King Saud University at 2 sites 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?
The sponsor lists 5 inclusion and 4 exclusion criteria. 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 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dr. Alaa M. Albishi, Assistant Professor (+966555090015, aalbeshi@ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Mayer Upper limb assessment (FMA) (time frame: at baseline, and after 2 weeks, and after intervention ( 4 weeks).). The study lists 4 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 8 Jan 2025.