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Search / Trial NCT06786000

Neurophysiological and Behavioral Effects of Combining Transcranial Direct Current Stimulation (tDCS) and Modified-Constraint Induced Movement Therapy (mCIMT)

Launched by KING SAUD UNIVERSITY · Jan 14, 2025

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Stroke Ischemic Stroke Hemorrhagic Stroke T Dcs M Cimt Hemiparesis Neural Activation Primary Motor Cortex Nibs Non Invasive Brain Stimulation Trans Direct Current Stimulation Modified Constraint Induced Movement Therapy

ClinConnect Summary

This clinical trial is studying how different types of brain stimulation, called transcranial direct current stimulation (tDCS), can help improve arm and hand movement in patients who have had a stroke. Specifically, researchers want to find out if using tDCS in different ways—bi-hemispheric, anodal, or cathodal—along with a therapy designed to improve movement (modified-Constraint Induced Movement Therapy or mCIMT) will lead to better outcomes for patients compared to a dummy treatment (sham tDCS).

To participate in this trial, individuals must be at least 18 years old, have experienced a stroke more than three months ago, and have some difficulties moving one arm. Participants will attend the clinic three times a week for four weeks and will receive a total of 12 therapy sessions. They will also undergo brain scans before and after the treatment to assess any changes. This trial is currently recruiting participants and aims to find effective ways to support stroke recovery and improve daily functioning for those affected.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Adult participants clinically diagnosed and confirmed by imaging of ischemic or hemorrhagic cerebrovascular accident (Dahl et al., 2008; Jin et al., 2019).
  • 2. Participant's age older than 18 years (Baltar et al., 2020).
  • 3. Stroke onset more than 3 months with unilateral motor deficits (Lin et al., 2010).
  • 4. Adequate cognitive function is required to follow instructions. The Arabic version of the Mini Mental State Examination (MMSE) should be ≥24 (Kim, 2021).
  • 5. 10° of active extension to the metacarpophalangeal and interphalangeal joints and 20° at wrist will be assessed by manual goniometer (Dahl et al., 2008).
  • 6. Fugl-Meyer assessment (FMA) scores between 19 and 58, indicating moderate to mild impairments.
  • 7. Not participating in other clinical, or research studies at the same time.
  • Exclusion Criteria:
  • 1. Severe muscle spasticity at the affected limb at all joints (the Modified Ashworth Scale scores \> 3) (Baltar et al., 2020).
  • 2. Contraindications to NIBS (Bornheim et al., 2019).
  • 3. Unilateral neglect (Dahl et al., 2008)
  • 4. Other neurologic or orthopedic conditions that may affect hand function.
  • 5. Unstable medical conditions.

About King Saud University

King Saud University (KSU), established in 1957, is a leading higher education institution in Saudi Arabia, renowned for its commitment to advancing research and innovation in various fields, including health sciences. With a robust infrastructure and a diverse pool of expert faculty, KSU actively engages in clinical trials aimed at improving healthcare outcomes and addressing pressing medical challenges. The university prioritizes ethical research practices and collaboration with local and international partners to contribute to the global body of medical knowledge, ultimately enhancing patient care and public health in the region and beyond.

Locations

Riyadh, , Saudi Arabia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported