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Investigating The Neurophysiological Mechanisms Of Transcranial Direct Current Stimulation Combined With Action Observation Therapy On Hand Muscle Neuroplasticity in Chronic Stroke

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Background: While both tDCS and AOT have shown promise individually for stroke rehabilitation, the neural mechanisms of their combined effects remain unclear. Understanding these mechanisms could optimise rehabilitation protocols and improve functional outcomes. Intervention: Participants will receive 10 sessions of anodal tDCS over the ipsilesional motor cortex combined with AOT over two weeks in a clinical setting, followed by 8 weeks of home-based AOT practice. Control groups will receive tDCS alone or AOT alone. Neurophysiological changes will be assessed using motor evoked potentials (MEPs) to evaluate corticospinal excitability. Clinical hand function will be assessed using standardised outcome measures. Measurements: Assessments will be conducted at baseline, during intervention (week 2), and after the home practice phase (week 10) to evaluate neuroplastic changes. Significance: This study will provide mechanistic insights into how neuromodulation and observational learning interact to promote motor recovery, informing evidence-based rehabilitation strategies for stroke survivors in Malaysia and globally. Study

Design: Randomised controlled trial with three parallel arms, recruiting 60 participants with chronic stroke from Sabah, Malaysia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 59
Healthy Volunteers: f
View:

• Adults aged 18 to 59 years

• Single episode of unilateral stroke and weakness in hand muscles 6 to 24 months post-stroke

• No excessive spasticity of the upper limb, defined as grade two or less on Modified Ashworth Scale

Locations
Other Locations
Malaysia
Hospital Universiti Malaysia Sabah (HUMS)
RECRUITING
Kota Kinabalu
Queen Elizabeth Hospital
ENROLLING_BY_INVITATION
Kota Kinabalu
Contact Information
Primary
Candace Goh Xiao Huey, Msc.
candace@moh.gov.my
+60-162316345
Backup
Fatimah Ahmedy, MRehabMed
fatimahmedy@ums.edu.my
+60-138805513
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2028-01-20
Participants
Target number of participants: 60
Treatments
Experimental: Active tDCS + AOT
Participants will receive anodal transcranial direct current stimulation (tDCS) at 2 mA for 20 minutes combined with action observation therapy (AOT) for 10 sessions over 2 weeks at an outpatient clinic. During tDCS delivery, participants will observe first-person perspective videos of hand motor tasks and practice the observed movements. Following the clinic phase, participants will continue AOT practice at home for 30 minutes once daily for 8 weeks.
Placebo_comparator: sham tDCS + AOT
Sham tDCS group - apply sham anodal tDCS with a 30s ramp-up and 30s ramp-down, switching the current to 0mA without the participant's awareness.~Administer sham anodal tDCS for 20 minutes. Concurrently perform AOT for 30 minutes.
Active_comparator: tDCS only
Administer active anodal tDCS for 20 minutes. Concurrently perform upper limb motor task actions with landscape video for 30 minutes.
Related Therapeutic Areas
Sponsors
Leads: Universiti Malaysia Sabah

This content was sourced from clinicaltrials.gov