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

Sponsor
King Saud University
Study ID
NCT06764797
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Direct Current Stimulation — 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.
  • Virtual reality — DEVICE
    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 therapy — DEVICE
    20 minutes of tDCS during 45 minutes of VRMT games.
  • Conventional physical therapy — OTHER
    45 minutes of conventional physical therapy with sham tDCS

Study Details

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.

Key Dates

Start date
Sep 19, 2023
Status verified
Jan 2025
Primary completion
May 31, 2025
Completion
Jul 21, 2025

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: anodal tDCS combined with VRMT
    20 minutes of anodal tDCS combined with 45 minutes of VRMT
  • Active Comparator: Anodal tDCS alone
    20 minutes of anodal tDCS alone
  • Active Comparator: VRMT alone, Sham tDCS
    45 minutes of VRMT alone, For the sham-tDCS, the current flow will be terminated after 30 seconds.
  • Sham Comparator: 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.

Primary Outcome Measure

Fugl-Mayer Upper limb assessment (FMA) [ Time Frame: at baseline, and after 2 weeks, and after intervention ( 4 weeks). ]

Central Contacts

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