Brain Stimulation Combined With Watching Hand Movements to Improve Hand Recovery in Chronic Stroke

NCT07400939 | Not Yet Recruiting DMC

• 1 other identifier: NMRR ID-24-00969-PKS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

This study investigates the neurophysiological and electrophysiological mechanisms underlying the combined use of transcranial direct current stimulation (tDCS) and action observation therapy (AOT) for hand motor recovery in individuals with stroke. 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.

Conditions

Hand; Motor Evoked Potential; EMG; Neuroplasticity; Stroke; tDCS; Action Observation Therapy; Neurophysiological Assessment

Keywords

stroke rehabilitation; transcranial direct current stimulation; action observation therapy; neuroplasticity; neurophysiological

Outcome Measures

Primary Outcomes (1)

• Motor Evoked Potentials (MEPs)

  Peak-to-peak amplitude of motor evoked potentials (MEPs) elicited by single-pulse transcranial magnetic stimulation (TMS) and recorded via surface electromyography (EMG) from hand muscles of the paretic upper limb. Assessment Method: * TMS delivers single pulses over ipsilesional primary motor cortex (M1 hand area) * Surface EMG electrodes record responses from first dorsal interosseous (FDI), abductor pollicis brevis (APB), and extensor carpi radialis (ECR) muscles * Motor hotspot identified (optimal scalp location producing largest MEPs) * Resting motor threshold determined * 15-20 MEPs recorded at 120% of resting motor threshold * Inter-stimulus interval: 5-7 seconds * MEP amplitude measured as peak-to-peak voltage in millivolts (mV)

  From enrolment to the end of treatment at 10 weeks

Study Arms (3)

Active tDCS + AOT

EXPERIMENTAL

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.

Other: tDCS; Other: Action Observation Therapy (AOT)

sham tDCS + AOT

PLACEBO COMPARATOR

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.

Other: Action Observation Therapy (AOT)

tDCS only

ACTIVE COMPARATOR

Administer active anodal tDCS for 20 minutes. Concurrently perform upper limb motor task actions with landscape video for 30 minutes.

Other: tDCS

Interventions

tDCS OTHER

* Stimulation type: Anodal stimulation * Electrode size: 5x7cm * Stimulation target: C3/C4 primary motor cortex (M1) based on the 10-20 international electroencephalography system * Stimulation intensity: 2 mA * Stimulation current density: 0.029-0.057 mA/cm2 Use tDCS with two saline-soaked surface sponge electrodes (5x7cm) applied to the scalp, secured with a headband. Stimulation intensity is set to 2mA, with 30s ramping up at the start and 30s ramping down at the end of stimulation.

Active tDCS + AOT; tDCS only

Action Observation Therapy (AOT) OTHER

Participants watch selected videos based on muscle grading of triceps, which include functional movement patterns and daily activity tasks of the upper limb. These videos are presented through a computer or mobile screen positioned at an appropriate distance from the participant to allow ample space for performing the required movements.

Active tDCS + AOT; sham tDCS + AOT

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients diagnosed with posterior circulation infarction
• Unable to follow commands due to poor cognitive function
• Unilateral neglect
• Homonymous hemianopia
• Other existing neurological disorders that lead to poor hand function
• Grade four or five hand muscle strength.

Sponsors & Collaborators

• Universiti Malaysia Sabah: lead

Study Sites (3)

Beaufort Hospital

Beaufort, Sabah, 89807, Malaysia

Location

Hospital Universiti Malaysia Sabah (HUMS)

Kota Kinabalu, Sabah, 88400, Malaysia

Location

Queen Elizabeth Hospital

Kota Kinabalu, Sabah, 88586, Malaysia

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Fatimah Ahmedy

  Universit Malaysia Sabah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candace Goh Xiao Huey, Msc.

CONTACT

+60-162316345; candace@moh.gov.my

Fatimah Ahmedy, MRehabMed

CONTACT

+60-138805513; fatimahmedy@ums.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 20, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-01

Locations

MY (3)