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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Saudi Arabia
King Saud University Medical City
RECRUITING
Riyadh
Contact Information
Primary
Alaa M. Albishi, PhD in Rehabilitation Sciences
aalbeshi@KSU.EDU.SA
+966555090015
Backup
Ahmad O. Alokaily, PhD
aalokaily@ksu.edu.sa
+966557447442
Time Frame
Start Date: 2023-04-11
Estimated Completion Date: 2025-04-11
Participants
Target number of participants: 300
Treatments
Experimental: Anodal tDCS combined with mCIMT
20 minutes of anodal tDCS followed by 1 hour of the mCIMT program
Experimental: Cathodal tDCS combined with mCIMT
20 minutes of cathodal tDCS followed by 1 hour of the mCIMT program
Experimental: Bihemispheric tDCS combined with mCIMT
20 minutes of bihemispheric tDCS followed by 1 hour of the mCIMT program
Sham_comparator: Sham tDCS combined with mCIMT
20 minutes of anodal tDCS (after 30 seconds of stimulation, the stimulator will switch off) followed by 1 hour of the mCIMT program
Related Therapeutic Areas
Sponsors
Leads: King Saud University
Collaborators: King Fahad Medical City, King Saud Medical City

This content was sourced from clinicaltrials.gov