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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-19

Study Completion Date

2025-07-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT07288385

Brain Diseases Central Nervous System Diseases Nervous System Diseases +2 more

RECRUITING NA

Combining tDCS With VR-based Motor Training in Stroke

NCT03144102

Virtual Reality Based Therapy Anodal tDCS Occupational Therapy +1 more

UNKNOWN NA

Mixed Reality and Virtual Reality Technology With Mirror Therapy for Stroke Rehabilitation

NCT05903235

Stroke Cerebrovascular Disorders Central Nervous System Diseases

RECRUITING NA

Effects of Virtual Reality Multisensory Cooperative Task-Oriented Mirror Therapy

NCT07139379

Stroke Rehabilitation Virtual Reality +2 more

NOT_YET_RECRUITING NA

Recovering Arm Function in Chronic Post-stroke Patients Using Combined HD-tDCS and Virtual Reality Therapy

NCT04291573

Chronic Post Stroke Individuals

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Rehabilitaion Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

anodal tDCS combined with VRMT

20 minutes of anodal tDCS combined with 45 minutes of VRMT

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy

Intervention Type DEVICE

20 minutes of tDCS during 45 minutes of VRMT games.

Anodal tDCS alone

20 minutes of anodal tDCS alone

Group Type ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type DEVICE

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.

VRMT alone, Sham tDCS

45 minutes of VRMT alone, For the sham-tDCS, the current flow will be terminated after 30 seconds.

Group Type ACTIVE_COMPARATOR

Virtual reality

Intervention Type DEVICE

The VRMT group will receive VRMT game-based training using their non-affected upper limb. using a semi-immersive motion-tracking device.

Conventional Physical therapy alone, Sham tDCS

45 minutes of conventional physical therapy, For the sham-tDCS, the current flow will be terminated after 30 seconds.

Group Type SHAM_COMPARATOR

Conventional physical therapy

Intervention Type OTHER

45 minutes of conventional physical therapy with sham tDCS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcranial Direct Current Stimulation

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.

Intervention Type DEVICE

Virtual reality

The VRMT group will receive VRMT game-based training using their non-affected upper limb. using a semi-immersive motion-tracking device.

Intervention Type DEVICE

Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy

20 minutes of tDCS during 45 minutes of VRMT games.

Intervention Type DEVICE

Conventional physical therapy

45 minutes of conventional physical therapy with sham tDCS

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No