Neurophysiological and Behavioral Effects of Combining Transcranial Direct Current Stimulation (tDCS) and Modified-Constraint Induced Movement Therapy (mCIMT)
Neurophysiological and Behavioral Effects of Combining Transcranial Direct Current Stimulation (tDCS) and Modified-Constraint Induced Movement Therapy (mCIMT) on Upper Limb Function Recovery in Patients with Stroke
King Saud University
300 participants
Apr 11, 2023
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria7
- 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).
- 10° of active extension to the metacarpophalangeal and interphalangeal joints and 20° at wrist will be assessed by manual goniometer (Dahl et al., 2008).
- Fugl-Meyer assessment (FMA) scores between 19 and 58, indicating moderate to mild impairments.
- Not participating in other clinical, or research studies at the same time.
Exclusion Criteria5
- 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.
- Unstable medical conditions.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
20 minutes of anodal tDCS followed by 1 hour of the mCIMT program. The anodal electrode will be placed over the ipsilesional M1 (primary motor cortex, C3 or C4 according to EEG 10/20 system), and the cathodal electrode over the contralateral supraorbital area (Fp1 or Fp2) ). Leading to subthreshold depolarization to promote cortical excitation. And twelve different oriented tasks will be used during the 1-hour training period.
20 minutes of cathodal tDCS followed by 1 hour of the mCIMT program. the cathodal electrode will be placed over the contralesional M1, and the anodal electrode over the contralateral supraorbital area (Fp1 or Fp2). leading to subthreshold polarization to promote cortical inhibition. And twelve different oriented tasks will be used during the 1-hour training period.
20 minutes of Bihemispheric tDCS followed by 1 hour of the mCIMT program. the cathodal electrode will be placed over the primary motor cortex (M1) of the contralesional hemisphere and the anodal electrode will be placed above the ipsilateral M1 position (C3 or C4 positions, according to the 10/20 EEG system). And twelve different oriented tasks will be used during the 1-hour training period.
20 minutes of sham tDCS followed by 1 hour of the mCIMT program. the same stimulation place and parameters will be used as in the anodal group. However, after 30 seconds of stimulation, the stimulator will switch off. This provides the participants with the experience of the initial itchy sensation that occurs during tDCS, which is required for efficient masking. And twelve different oriented tasks will be used during the 1-hour training period.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06786000