StrokeNCT07400939
Brain Stimulation Combined With Watching Hand Movements to Improve Hand Recovery in Chronic Stroke
A study testing tDCS and Action Observation Therapy (AOT) in people with Stroke and tDCS, run by Universiti Malaysia Sabah at 2 sites in Malaysia.
Trial summary
This study investigates the neurophysiological mechanisms underlying the combined use of transcranial direct current stimulation (tDCS) and action observation therapy (AOT) for hand motor recovery in individuals with stroke. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Stroke, tDCS, Action Observation Therapy
- What is being tested?
- tDCS and Action Observation Therapy (AOT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesMalaysia
- Study dates
- 1 Apr 2026to 20 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia2 sites, 2 recruiting
- Recruiting
Hospital Universiti Malaysia Sabah (HUMS)
Kota Kinabalu, Sabah, 88400
Fatimah Ahmedy, MRehabMed, +60-138805513, fatimahmedy@ums.edu.my
- Enrolling by invitation
Queen Elizabeth Hospital
Kota Kinabalu, Sabah, 88586
About this study
Official title: Investigating The Neurophysiological Mechanisms Of Transcranial Direct Current Stimulation Combined With Action Observation Therapy On Hand Muscle Neuroplasticity in Chronic Stroke
This study investigates the neurophysiological 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.
Read the detailed description
The participation duration for each participant is 10 weeks, including the assessment period.
Group 1 tDCS + AOT (intervention): tDCS will be administered at the outpatient clinic for 20 minutes per session, for a total of 10 sessions over two consecutive weeks. During the tDCS sessions, each participant will engage in AOT for 30 minutes under the supervision of a therapist. Subsequently, each participant will continue performing AOT at home for 30 minutes per session, once a day, five days per week, for 8 consecutive weeks.
Group 2 tDCS alone (control): tDCS will be administered at the outpatient clinic for 20 minutes per session, for a total of 10 sessions over two consecutive weeks. During the tDCS sessions, each participant will watch a landscape video for 30 minutes. Subsequently, each patient will continue watching the landscape video at home for 30 minutes per session, once a day, five days per week, for 8 consecutive weeks.
Group 3 AOT alone (control): placebo tDCS will be administered at the outpatient clinic for 20 minutes per session, for a total of 10 sessions over 2 consecutive weeks. During the placebo tDCS sessions, each participant will engage in AOT for 30 minutes under the supervision of a therapist. Following the clinic sessions, each patient will continue performing AOT at home for 30 minutes per session, once a day, five days per week, for 8 consecutive weeks.
The principal investigator will visit each research site throughout the duration of the study. All participants will attend the outpatient rehabilitation setting five times a week for 30 minutes per session, for 2 consecutive weeks, and continue intervention at home for five days a week for 8 consecutive weeks. The total intervention duration consists of 10 consecutive weeks. For each session in the hospital, there will be a physiotherapist to monitor participants' compliance with the interventions and to ensure that the training is conducted as per protocol. Level of participation would be measured by Rating of Perceived Exertion Scale of 3-5 (light activity to somewhat hard). If the subject attended the session but refuse to participate in the intervention, the subject would be excluded from the study.
- Conditions
- Stroke, tDCS, Action Observation Therapy, Hand, Motor Evoked Potential, EMG
- Being tested
- tDCS, Action Observation Therapy (AOT)
- Keywords
- stroke rehabilitation, transcranial direct current stimulation, action observation therapy, neuroplasticity, neurophysiological
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSOther
- 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrolment to the end of treatment at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Apr 2026
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Malaysia Sabah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candace Goh Xiao Huey, Universiti Malaysia Sabah
- Investigators
- Fatimah Ahmedy, Principal investigator, Universit Malaysia Sabah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400939
- Sponsor's protocol ID
- NMRR ID-24-00969-PKS
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating The Neurophysiological Mechanisms Of Transcranial Direct Current Stimulation Combined With Action Observation Therapy On Hand Muscle Neuroplasticity in Chronic Stroke
- ClinicalTrials.gov ID
- NCT07400939
- Acronym / sponsor ID
- NMRR ID-24-00969-PKS
- Conditions
- Stroke, tDCS, Action Observation Therapy, Hand, Motor Evoked Potential, EMG
- Keywords
- stroke rehabilitation, transcranial direct current stimulation, action observation therapy, neuroplasticity, neurophysiological
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universiti Malaysia SabahUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Jan 2028 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the neurophysiological 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.
Detailed description
The participation duration for each participant is 10 weeks, including the assessment period.
Group 1 tDCS + AOT (intervention): tDCS will be administered at the outpatient clinic for 20 minutes per session, for a total of 10 sessions over two consecutive weeks. During the tDCS sessions, each participant will engage in AOT for 30 minutes under the supervision of a therapist. Subsequently, each participant will continue performing AOT at home for 30 minutes per session, once a day, five days per week, for 8 consecutive weeks.
Group 2 tDCS alone (control): tDCS will be administered at the outpatient clinic for 20 minutes per session, for a total of 10 sessions over two consecutive weeks. During the tDCS sessions, each participant will watch a landscape video for 30 minutes. Subsequently, each patient will continue watching the landscape video at home for 30 minutes per session, once a day, five days per week, for 8 consecutive weeks.
Group 3 AOT alone (control): placebo tDCS will be administered at the outpatient clinic for 20 minutes per session, for a total of 10 sessions over 2 consecutive weeks. During the placebo tDCS sessions, each participant will engage in AOT for 30 minutes under the supervision of a therapist. Following the clinic sessions, each patient will continue performing AOT at home for 30 minutes per session, once a day, five days per week, for 8 consecutive weeks.
The principal investigator will visit each research site throughout the duration of the study. All participants will attend the outpatient rehabilitation setting five times a week for 30 minutes per session, for 2 consecutive weeks, and continue intervention at home for five days a week for 8 consecutive weeks. The total intervention duration consists of 10 consecutive weeks. For each session in the hospital, there will be a physiotherapist to monitor participants' compliance with the interventions and to ensure that the training is conducted as per protocol. Level of participation would be measured by Rating of Perceived Exertion Scale of 3-5 (light activity to somewhat hard). If the subject attended the session but refuse to participate in the intervention, the subject would be excluded from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active tDCS + AOT | Experimental | Other: tDCS, Other: Action Observation Therapy (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. |
| sham tDCS + AOT | Placebo comparator | Other: Action Observation Therapy (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. |
| tDCS only | Active comparator | Other: tDCSAdminister active anodal tDCS for 20 minutes. Concurrently perform upper limb motor task actions with landscape video for 30 minutes. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS* 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. | Other | Active tDCS + AOT, tDCS only |
| Action Observation Therapy (AOT)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. | Other | Active tDCS + AOT, sham tDCS + AOT |
Primary outcome
Motor Evoked Potentials (MEPs)
Time frame: From enrolment to the end of treatment at 10 weeks
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatimah Ahmedy principal investigator
Universit Malaysia Sabah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and Action Observation Therapy (AOT) in people with Stroke and tDCS, run by Universiti Malaysia Sabah at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Candace Goh Xiao Huey, Msc. (+60-162316345, candace@moh.gov.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Evoked Potentials (MEPs) (time frame: From enrolment to the end of treatment at 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.