About this trial
This clinical trial aims to evaluate the effect of different types of tDCS modulation with mCIMT in improving affected upper-limb motor function for stroke patients. The main question it seeks to answer:
Which type of tDCS (bi-hemispheric, anodal, or cathodal) combined with the mCIMT program leads to greater improvement in affected upper-limb function in patients with stroke? Researchers will compare these three types of tDCS to a sham tDCS. To see which kind of tDCS protocol combined with the mCIMT program will be more effective in improving affected upper-limb function for stroke patients.
Participants will:
1. Participants will receive 12 sessions of mCIMT combined with tDCS or mCIMT alone. 2. Visit the clinic three times a week for four weeks. 3. Participants will do fMRI and TMS before and after the program and three times of assessment before and after two weeks after the program.
Eligibility criteria
Qualifiers
Adult participants clinically diagnosed and confirmed by imaging of ischemic or hemorrhagic cerebrovascular accident (Dahl et al., 2008; Jin et al., 2019).
Participant's age older than 18 years (Baltar et al., 2020).
Stroke onset more than 3 months with unilateral motor deficits (Lin et al., 2010).
Adequate cognitive function is required to follow instructions. The Arabic version of the Mini Mental State Examination (MMSE) should be ≥24 (Kim, 2021).
Disqualifiers
Severe muscle spasticity at the affected limb at all joints (the Modified Ashworth Scale scores > 3) (Baltar et al., 2020).
Contraindications to NIBS (Bornheim et al., 2019).
Unilateral neglect (Dahl et al., 2008)
Other neurologic or orthopedic conditions that may affect hand function.
Trial design
Treatments tested in this trial
- Anodal tDCS combined with mCIMT
- Cathodal tDCS combined with mCIMT
- Bihemispheric tDCS combined with mCIMT
- Sham tDCS combined with mCIMT
Treatment groups
Sponsors and collaborators
King Saud University
Lead sponsor
King Saud Medical City
Collaborator
King Fahad Medical City
Collaborator