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

King Saud University

Status and phase: Enrolling; Phase 3

Conditions: Stroke Rehabilitaion; Stroke

Treatments: Device: Virtual reality; Other: Conventional physical therapy; Device: Transcranial Direct Current Stimulation; Device: Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06764797

E-23-7496

Not funded (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 4 patient groups

anodal tDCS combined with VRMT

Experimental group

Description:

20 minutes of anodal tDCS combined with 45 minutes of VRMT

Treatment:

Device: Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy

Anodal tDCS alone

Active Comparator group

Description:

20 minutes of anodal tDCS alone

Treatment:

Device: Transcranial Direct Current Stimulation

VRMT alone, Sham tDCS

Active Comparator group

Description:

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

Treatment:

Device: Virtual reality

Conventional Physical therapy alone, Sham tDCS

Sham Comparator group

Description:

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

Treatment:

Other: Conventional physical therapy