StrokeNCT05608525
Upper Limb tDCS in Chronic Stroke Patients (NOURISH)
A study testing transcranial current stimulation and GRASP in people with Stroke, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This study is a randomized double-blinded trial investigating the effect of Transcranial Direct Current stimulation (tDCS) on upper limb motor function rehabilitation in chronic stroke patients. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- transcranial current stimulation and GRASP
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteSingapore
- Study dates
- 16 Feb 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-80 years old;
- First ever stroke, 6 months to 2 years after stroke onset;
- ARAT≤42
Who cannot join
- Pregnancy;
- Any metal implants inside the body that are contraindications of MRI scan;
- cardiac pacemakers;
- History of epilepsy;
- Sensorimotor disturbance due to other causes other than stroke;
- Claustrophobia;
Show all 10Show fewer
- Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
- Major depression and a history of psychotic disorders;
- Terminal diagnosis with life expectancy <=1 year. Any metal implants inside the body that are contraindications of MRI scan;
- 3. cardiac pacemakers; 4. History of epilepsy; 5. Sensorimotor disturbance due to other causes other than stroke; 6. Claustrophobia; 7. Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina; 8. Major depression and a history of psychotic disorders; 9. Terminal diagnosis with life expectancy <=1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcranial Direct Current Stimulation on Upper Limb Motor Rehabilitation in Chronic Stroke Patients
This study is a randomized double-blinded trial investigating the effect of Transcranial Direct Current stimulation (tDCS) on upper limb motor function rehabilitation in chronic stroke patients.
51 subjects will be recruited from National University Hospital (NUH) and be randomized to receive one of the followings:
Read more
- Group 1 will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb;
- Group 2 to receive 1mA anodal tDCS to the contralesional premotor cortex;
- Group 3 to receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1. tDCS will be performed once a day together with standardized occupational therapy (GRASP) for 20 sessions within 30 days. Group 1 and Group 2 will receive tDCS for 20 minutes during each session, while Group 3 only receives the current stimulation for 20 seconds. GRASP will be performed daily together with tDCS, either concurrently with or immediately after tDCS stimulation.
The outcome measures will be measured at baseline, after intervention and 1 month after intervention, including:
- TMS measurement of corticospinal excitability;
- functional MRI scan;
- High density EEG (HD-EEG) evaluation;
- Clinical measures on upper limb motor function;
- Cognitive tests.
Read the detailed description
This study is a randomized double-blinded trial investigating the effect of Transcranial Direct Current stimulation (tDCS) on upper limb motor function rehabilitation in chronic stroke patients.
51 subjects will be recruited from National University Hospital (NUH). Once subject is identified to be eligible for the study and is agreeable to participate into the study, the following will be measured/performed:
- TMS measurement of corticospinal excitability: resting motor threshold and/or active motor threshold, intracortical facilitation, short interval intracortical inhibition, silent period.
- MRI scan: Participants will go through the following image acquisition procedures at NUS TMR (Centre for Translational MR Research): 1) a functional MRI scans for brain activity together with motor task. 2) a 3D MPRAGE sequence for brain structure. 3) an advanced multishell high-resolution diffusion MRI for characterizing brain microstructure and extracellular space. 4) a FLAIR scan to measure white matter hyperintensity. Both functional and anatomical image acquisition will be undertaken using but not limited to gradient echo EPI sequence or its modified version (Feinberg \& Setsompop, 2013). Signal stability during imaging is assured by a daily prescan QC routine. Contrast MRI will not be performed in this study. The MRI scan will take about 1 hours. The whole procedure including briefing and preparation will be about 1.5 hours.
- High density EEG (HD-EEG) evaluation of the electrical activity of the brain.
- Clinical measures on upper limb motor function:
- upper extremity portion of Fugl-Meyer Assessment (UE-FMA)
- Action Research Arm test (ARAT)
- Modified Ashworth scale for spasticity (MAS)
- Isometric elbow flexion strength
- Handgrip strength
- Cognitive tests:
- Digit Span Task
- Digit Symbol Modalities Task
- Trail-making test (TMT)-A \&B
- Clock-Drawing Test (CDT)
- Controlled Oral Word Association Test (COWAT) -animals \& FAS
- Mini-Mental State Exam (MMSE)
- Rey Auditory Verbal Learning Test (RAVL)
- Spatial span forward/backward test
- Visuospatial Paired Associate Learning (VPA)
- Randomization: Subject will be randomized into 3 groups using Microsoft Excel, to receive different types of stimulation:
- Group 1 will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb;
- Group 2 to receive 1mA anodal tDCS to the contralesional premotor cortex;
- Group 3 to receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1.
The assessor of the outcome measures and subject will be blinded to the tDCS intervention that subject will be receiving.
After the outcome measures (Pre Assessment) are done, tDCS will be performed once a day together with standardized occupational therapy (GRASP) for 20 sessions within 30 days.
Direct current will be delivered by a battery-operated, constant current stimulator (HDCstim, Magstim), through 2 rubber electrodes embedded in a pair of saline-soaked sponge bag. Stimulation intensity will be ramped up to 1 mA over 30 seconds and maintain at 1 mA for 30 minutes, and then ramped down to 0 mA over 20 seconds. Sham-tDCS was delivered by similarly ramping up to 1 mA but maintained for only 20 seconds to give subjects the same scalp sensation, before ramping down. Cathode for all 3 tDCS groups will be used as reference electrode and placed over the supraorbital area contralateral to the anode.
Three options will be provided for subject to decide where the 20 sessions of tDCS intervention will be performed. Subject could choose either 1 option or "mixed option".
- At NUH: which is recommended by the study team.
- At home and assisted by caregiver: For subject's convenience and to minimize the number of hospital visits especially during unforeseen circumstance like COVID outbreak, subject is allowed to bring tDCS device (Stimulator only) back to use at home after the caregiver is properly trained. Literature has shown that administration of tDCS at home by patient and caregiver is feasible and safe [13]. The protocol details of tDCS home usage is elaborated in the document "Study Protocol".
- At home and assisted by research staff: Research staff can go subject's home to perform tDCS stimulation. In this case, tDCS stimulator will be kept by research staff.
A standardized occupational therapy- GRASP will be performed daily together with tDCS over the period between the Pre Assessment and the Post Assessment. GRASP exercise will be administered concurrently with or immediately after tDCS stimulation. GRASP is a self-directed arm and hand exercise program for which is supervised by a therapist, but done independently by the participant (and with their family if possible). GRASP has been shown to improve arm and hand function and strength in stroke patients in community [22-27]. The versions of the program- Home GRASP will be used. All occupational tasks will be selected from the GRASP task pool and be progressed according to the GRASP protocol (https://neurorehab.med.ubc.ca/grasp). Each GRASP session will take about 1 hour. A total of 20 GRASP sessions will be administered.
The same outcome measures will be performed again after 20 sessions of tDCS (Post Assessment), and 1 month after the tDCS intervention (Follow-up Assessment), except that MRI scan will not be performed at Post Assessment.
- Conditions
- Stroke
- Being tested
- transcranial current stimulation, GRASP
- Keywords
- stroke, motor recovery, transcranial direct current stimulation, corticospinal excitability, neuromodulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial current stimulationDevice
A trained research staff or physician will perform tDCS to the subject. Direct current will be delivered by a battery-operated, constant current stimulator, through 2 rubber electrodes embedded in a pair of saline-soaked sponge bag. Stimulation intensity will be ramped up to 1 mA over 30 seconds and maintain at 1 mA for 20 minutes, and then ramped down to 0 mA over 30 seconds.
GRASPBehavioural
A standardized occupational therapy- GRASP will be performed daily together with tDCS over the period between the Pre Assessment and the Post Assessment. GRASP exercise will be administered concurrently with or immediately after tDCS stimulation. GRASP is a self-directed arm and hand exercise program for which is supervised by a therapist, but done independently by the participant (and with their family if possible). GRASP has been shown to improve arm and hand function and strength in stroke patients in community [22-27]. The versions of the program- Home GRASP will be used. All occupational tasks will be selected from the GRASP task pool and be progressed according to the GRASP protocol (https://neurorehab.med.ubc.ca/grasp). Each GRASP session will take about 1 hour. A total of 20 GRASP sessions will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS stimulation to the ipsilesional M1 | Experimental | Participant will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb.
Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training. Receives: Device: transcranial current stimulation; Behavioral: GRASP |
| Anodal tDCS to the contralesional premotor cortex | Experimental | Participant will receive 1mA anodal tDCS to the contralesional premotor cortex. Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training. Receives: Device: transcranial current stimulation; Behavioral: GRASP |
| Sham tDCS | Sham comparator | Participant will receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1.
Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training. Receives: Device: transcranial current stimulation; Behavioral: GRASP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical excitability measured by Transcranial Magnetic Stimulation (TMS)
measures of cortical excitability for those without TMS contraindications
Measured: Month 0
Cortical excitability measured by Transcranial Magnetic Stimulation (TMS)
measures of cortical excitability for those without TMS contraindications
Measured: Month 1
Cortical excitability measured by Transcranial Magnetic Stimulation (TMS)
measures of cortical excitability for those without TMS contraindications
Measured: Month 2
neural excitability measured by Magnetic resonance imaging (MRI) scan
Participants will go through one of the following image acquisition procedures 1) a functional MRI scans for brain activity together with motor task. 2) a 3D MPRAGE sequence for brain structure. 3) an advanced multishell high-resolution diffusion MRI for characterizing brain microstructure and extracellular space. 4) a FLAIR scan to measure white matter hyperintensity. Both functional and anatomical image acquisition will be undertaken using but not limited to gradient echo EPI sequence or its modified version.
Measured: Month 0
neural excitability measured by Magnetic resonance imaging (MRI) scan
Participants will go through one of the following image acquisition procedures 1) a functional MRI scans for brain activity together with motor task. 2) a 3D MPRAGE sequence for brain structure. 3) an advanced multishell high-resolution diffusion MRI for characterizing brain microstructure and extracellular space. 4) a FLAIR scan to measure white matter hyperintensity. Both functional and anatomical image acquisition will be undertaken using but not limited to gradient echo EPI sequence or its modified version.
Measured: Month 2
neural excitability measured by electroencephalogram (EEG)
High density EEG (electroencephalogram) evaluation of the electrical activity of the brain
Measured: Month 0
neural excitability measured by electroencephalogram (EEG)
High density EEG (electroencephalogram) evaluation of the electrical activity of the brain
Measured: Month 1
neural excitability measured by electroencephalogram (EEG)
High density EEG (electroencephalogram) evaluation of the electrical activity of the brain
Measured: Month 2
upper extremity motor function using Fugl-Meyer scale
Upper limb function, Minimum score 0, Maximum score 66, the higher the score the better the upper limb function.
Measured: Month 0
upper extremity motor function using Fugl-Meyer scale
Upper limb function, Minimum score 0, Maximum score 66, the higher the score the better the upper limb function.
Measured: Month 1
upper extremity motor function using Fugl-Meyer scale
Upper limb function, Minimum score 0, Maximum score 66, the higher the score the better the upper limb function.
Measured: Month 2
Action Research Arm Test
Test for upper extremity performance (coordination, dexterity and functioning). Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.
Measured: Month 0
Action Research Arm Test
Test for upper extremity performance (coordination, dexterity and functioning). Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.
Measured: Month 1
Action Research Arm Test
Test for upper extremity performance (coordination, dexterity and functioning). Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.
Measured: Month 2
Modified Ashworth scale for spasticity (MAS)
Test for muscle spasticity. 6 point scale, Scores range from 0 to 4 (namely 0, 1, 1+, 2, 3 and 4), where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.
Measured: Month 0
Modified Ashworth scale for spasticity (MAS)
Test for muscle spasticity. 6 point scale, Scores range from 0 to 4 (namely 0, 1, 1+, 2, 3 and 4), where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.
Measured: Month 1
Modified Ashworth scale for spasticity (MAS)
Test for muscle spasticity. 6 point scale, Scores range from 0 to 4 (namely 0, 1, 1+, 2, 3 and 4), where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start16 Feb 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
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.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomized to receive one of the followings: * Group 1 will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb; * Group 2 to receive 1mA anodal tDCS to the contralesional premotor cortex; * Group 3 to receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Effie Chew, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608525
- Sponsor's protocol ID
- 2022/00686
- Status last verified
- Sep 2025
- First submitted
- 1 Nov 2022
- Last updated
- 23 Feb 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 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation on Upper Limb Motor Rehabilitation in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05608525
- Acronym / sponsor ID
- 2022/00686
- Conditions
- Stroke
- Keywords
- stroke, motor recovery, transcranial direct current stimulation, corticospinal excitability, neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 8 Nov 2022 (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 is a randomized double-blinded trial investigating the effect of Transcranial Direct Current stimulation (tDCS) on upper limb motor function rehabilitation in chronic stroke patients.
51 subjects will be recruited from National University Hospital (NUH) and be randomized to receive one of the followings:
- Group 1 will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb;
- Group 2 to receive 1mA anodal tDCS to the contralesional premotor cortex;
- Group 3 to receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1. tDCS will be performed once a day together with standardized occupational therapy (GRASP) for 20 sessions within 30 days. Group 1 and Group 2 will receive tDCS for 20 minutes during each session, while Group 3 only receives the current stimulation for 20 seconds. GRASP will be performed daily together with tDCS, either concurrently with or immediately after tDCS stimulation.
The outcome measures will be measured at baseline, after intervention and 1 month after intervention, including:
- TMS measurement of corticospinal excitability;
- functional MRI scan;
- High density EEG (HD-EEG) evaluation;
- Clinical measures on upper limb motor function;
- Cognitive tests.
Detailed description
This study is a randomized double-blinded trial investigating the effect of Transcranial Direct Current stimulation (tDCS) on upper limb motor function rehabilitation in chronic stroke patients.
51 subjects will be recruited from National University Hospital (NUH). Once subject is identified to be eligible for the study and is agreeable to participate into the study, the following will be measured/performed:
- TMS measurement of corticospinal excitability: resting motor threshold and/or active motor threshold, intracortical facilitation, short interval intracortical inhibition, silent period.
- MRI scan: Participants will go through the following image acquisition procedures at NUS TMR (Centre for Translational MR Research): 1) a functional MRI scans for brain activity together with motor task. 2) a 3D MPRAGE sequence for brain structure. 3) an advanced multishell high-resolution diffusion MRI for characterizing brain microstructure and extracellular space. 4) a FLAIR scan to measure white matter hyperintensity. Both functional and anatomical image acquisition will be undertaken using but not limited to gradient echo EPI sequence or its modified version (Feinberg \& Setsompop, 2013). Signal stability during imaging is assured by a daily prescan QC routine. Contrast MRI will not be performed in this study. The MRI scan will take about 1 hours. The whole procedure including briefing and preparation will be about 1.5 hours.
- High density EEG (HD-EEG) evaluation of the electrical activity of the brain.
- Clinical measures on upper limb motor function:
- upper extremity portion of Fugl-Meyer Assessment (UE-FMA)
- Action Research Arm test (ARAT)
- Modified Ashworth scale for spasticity (MAS)
- Isometric elbow flexion strength
- Handgrip strength
- Cognitive tests:
- Digit Span Task
- Digit Symbol Modalities Task
- Trail-making test (TMT)-A \&B
- Clock-Drawing Test (CDT)
- Controlled Oral Word Association Test (COWAT) -animals \& FAS
- Mini-Mental State Exam (MMSE)
- Rey Auditory Verbal Learning Test (RAVL)
- Spatial span forward/backward test
- Visuospatial Paired Associate Learning (VPA)
- Randomization: Subject will be randomized into 3 groups using Microsoft Excel, to receive different types of stimulation:
- Group 1 will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb;
- Group 2 to receive 1mA anodal tDCS to the contralesional premotor cortex;
- Group 3 to receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1.
The assessor of the outcome measures and subject will be blinded to the tDCS intervention that subject will be receiving.
After the outcome measures (Pre Assessment) are done, tDCS will be performed once a day together with standardized occupational therapy (GRASP) for 20 sessions within 30 days.
Direct current will be delivered by a battery-operated, constant current stimulator (HDCstim, Magstim), through 2 rubber electrodes embedded in a pair of saline-soaked sponge bag. Stimulation intensity will be ramped up to 1 mA over 30 seconds and maintain at 1 mA for 30 minutes, and then ramped down to 0 mA over 20 seconds. Sham-tDCS was delivered by similarly ramping up to 1 mA but maintained for only 20 seconds to give subjects the same scalp sensation, before ramping down. Cathode for all 3 tDCS groups will be used as reference electrode and placed over the supraorbital area contralateral to the anode.
Three options will be provided for subject to decide where the 20 sessions of tDCS intervention will be performed. Subject could choose either 1 option or "mixed option".
- At NUH: which is recommended by the study team.
- At home and assisted by caregiver: For subject's convenience and to minimize the number of hospital visits especially during unforeseen circumstance like COVID outbreak, subject is allowed to bring tDCS device (Stimulator only) back to use at home after the caregiver is properly trained. Literature has shown that administration of tDCS at home by patient and caregiver is feasible and safe [13]. The protocol details of tDCS home usage is elaborated in the document "Study Protocol".
- At home and assisted by research staff: Research staff can go subject's home to perform tDCS stimulation. In this case, tDCS stimulator will be kept by research staff.
A standardized occupational therapy- GRASP will be performed daily together with tDCS over the period between the Pre Assessment and the Post Assessment. GRASP exercise will be administered concurrently with or immediately after tDCS stimulation. GRASP is a self-directed arm and hand exercise program for which is supervised by a therapist, but done independently by the participant (and with their family if possible). GRASP has been shown to improve arm and hand function and strength in stroke patients in community [22-27]. The versions of the program- Home GRASP will be used. All occupational tasks will be selected from the GRASP task pool and be progressed according to the GRASP protocol (https://neurorehab.med.ubc.ca/grasp). Each GRASP session will take about 1 hour. A total of 20 GRASP sessions will be administered.
The same outcome measures will be performed again after 20 sessions of tDCS (Post Assessment), and 1 month after the tDCS intervention (Follow-up Assessment), except that MRI scan will not be performed at Post Assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized to receive one of the followings: * Group 1 will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb; * Group 2 to receive 1mA anodal tDCS to the contralesional premotor cortex; * Group 3 to receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1.
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS stimulation to the ipsilesional M1 | Experimental | Device: transcranial current stimulation, Behavioral: GRASPParticipant will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb. Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training. |
| Anodal tDCS to the contralesional premotor cortex | Experimental | Device: transcranial current stimulation, Behavioral: GRASPParticipant will receive 1mA anodal tDCS to the contralesional premotor cortex. Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training. |
| Sham tDCS | Sham comparator | Device: transcranial current stimulation, Behavioral: GRASPParticipant will receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1. Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 21-80 years old;
- First ever stroke, 6 months to 2 years after stroke onset;
- ARAT≤42
Key exclusion criteria (10 listed)
- Pregnancy;
- Any metal implants inside the body that are contraindications of MRI scan;
- cardiac pacemakers;
- History of epilepsy;
- Sensorimotor disturbance due to other causes other than stroke;
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 |
|---|---|---|
| transcranial current stimulationA trained research staff or physician will perform tDCS to the subject. Direct current will be delivered by a battery-operated, constant current stimulator, through 2 rubber electrodes embedded in a pair of saline-soaked sponge bag. Stimulation intensity will be ramped up to 1 mA over 30 seconds and maintain at 1 mA for 20 minutes, and then ramped down to 0 mA over 30 seconds. | Device | Anodal tDCS stimulation to the ipsilesional M1, Anodal tDCS to the contralesional premotor cortex, Sham tDCS |
| GRASPA standardized occupational therapy- GRASP will be performed daily together with tDCS over the period between the Pre Assessment and the Post Assessment. GRASP exercise will be administered concurrently with or immediately after tDCS stimulation. GRASP is a self-directed arm and hand exercise program for which is supervised by a therapist, but done independently by the participant (and with their family if possible). GRASP has been shown to improve arm and hand function and strength in stroke patients in community [22-27]. The versions of the program- Home GRASP will be used. All occupational tasks will be selected from the GRASP task pool and be progressed according to the GRASP protocol (https://neurorehab.med.ubc.ca/grasp). Each GRASP session will take about 1 hour. A total of 20 GRASP sessions will be administered. | Behavioural | Anodal tDCS stimulation to the ipsilesional M1, Anodal tDCS to the contralesional premotor cortex, Sham tDCS |
Primary outcome
Cortical excitability measured by Transcranial Magnetic Stimulation (TMS)
Time frame: Month 0
measures of cortical excitability for those without TMS contraindications
Cortical excitability measured by Transcranial Magnetic Stimulation (TMS)
Time frame: Month 1
measures of cortical excitability for those without TMS contraindications
Cortical excitability measured by Transcranial Magnetic Stimulation (TMS)
Time frame: Month 2
measures of cortical excitability for those without TMS contraindications
neural excitability measured by Magnetic resonance imaging (MRI) scan
Time frame: Month 0
Participants will go through one of the following image acquisition procedures 1) a functional MRI scans for brain activity together with motor task. 2) a 3D MPRAGE sequence for brain structure. 3) an advanced multishell high-resolution diffusion MRI for characterizing brain microstructure and extracellular space. 4) a FLAIR scan to measure white matter hyperintensity. Both functional and anatomical image acquisition will be undertaken using but not limited to gradient echo EPI sequence or its modified version.
neural excitability measured by Magnetic resonance imaging (MRI) scan
Time frame: Month 2
Participants will go through one of the following image acquisition procedures 1) a functional MRI scans for brain activity together with motor task. 2) a 3D MPRAGE sequence for brain structure. 3) an advanced multishell high-resolution diffusion MRI for characterizing brain microstructure and extracellular space. 4) a FLAIR scan to measure white matter hyperintensity. Both functional and anatomical image acquisition will be undertaken using but not limited to gradient echo EPI sequence or its modified version.
neural excitability measured by electroencephalogram (EEG)
Time frame: Month 0
High density EEG (electroencephalogram) evaluation of the electrical activity of the brain
neural excitability measured by electroencephalogram (EEG)
Time frame: Month 1
High density EEG (electroencephalogram) evaluation of the electrical activity of the brain
neural excitability measured by electroencephalogram (EEG)
Time frame: Month 2
High density EEG (electroencephalogram) evaluation of the electrical activity of the brain
upper extremity motor function using Fugl-Meyer scale
Time frame: Month 0
Upper limb function, Minimum score 0, Maximum score 66, the higher the score the better the upper limb function.
upper extremity motor function using Fugl-Meyer scale
Time frame: Month 1
Upper limb function, Minimum score 0, Maximum score 66, the higher the score the better the upper limb function.
upper extremity motor function using Fugl-Meyer scale
Time frame: Month 2
Upper limb function, Minimum score 0, Maximum score 66, the higher the score the better the upper limb function.
Action Research Arm Test
Time frame: Month 0
Test for upper extremity performance (coordination, dexterity and functioning). Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.
Action Research Arm Test
Time frame: Month 1
Test for upper extremity performance (coordination, dexterity and functioning). Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.
Action Research Arm Test
Time frame: Month 2
Test for upper extremity performance (coordination, dexterity and functioning). Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.
Modified Ashworth scale for spasticity (MAS)
Time frame: Month 0
Test for muscle spasticity. 6 point scale, Scores range from 0 to 4 (namely 0, 1, 1+, 2, 3 and 4), where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.
Modified Ashworth scale for spasticity (MAS)
Time frame: Month 1
Test for muscle spasticity. 6 point scale, Scores range from 0 to 4 (namely 0, 1, 1+, 2, 3 and 4), where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.
Modified Ashworth scale for spasticity (MAS)
Time frame: Month 2
Test for muscle spasticity. 6 point scale, Scores range from 0 to 4 (namely 0, 1, 1+, 2, 3 and 4), where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 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. This study is not recruiting at the moment.
Effie Chew, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial current stimulation and GRASP in people with Stroke, run by National University Hospital, Singapore at 1 site in Singapore.
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 10 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: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical excitability measured by Transcranial Magnetic Stimulation (TMS) (time frame: Month 0). The study lists 17 primary outcomes in all. 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 23 Feb 2026.