StrokeNCT07786649
Evaluating Different Protocols of Non-invasive Brain Stimulation (NIBS) in Stroke Rehabilitation
A study testing noninvasive brain stimulation (NIBS) including transcranial direct current stimulation (tDCS) and repetitive TMS (rTMS) in people with Stroke, run by National University Hospital, Singapore at 2 sites in Singapore.
Trial summary
This study aims to improve brain stimulation techniques for stroke patients dealing with motor and language issues. Researchers believe that current practices lack clarity because patients aren't grouped effectively and stimulation methods vary widely. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- noninvasive brain stimulation (NIBS) including transcranial direct current stimulation (tDCS) and repetitive TMS (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesSingapore
- Study dates
- 5 Aug 2024to 30 Nov 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-80 years old;
- Diagnosis of stroke, with good premorbid function.
- Presenting with at least 1 of the following functional impairment:
- 3a. Upper limb motor impairment with the sum of Medical Research Council grades for shoulder abduction and finger Extension (SAFE) ≤ 8; 3b. Lower limb motor impairment with Functional Ambulation Classification (FAC) 0-3; 3c. Neglect as assessed by Behavioural Inattention Test with a cut-off of \<129 and Catherine Bergego Scale with a cut-off of \>5/30 3d. Expressive Aphasia as indicated by AusTOMS score of 1-4 (mild to severe) in the Language and Speech scales 4. Being able to follow instruction and give consent.
Who cannot join
- Pregnancy;
- cardiac pacemakers;
- Sensorimotor disturbance due to other causes other than stroke;
- 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;
- Claustrophobia for those undergoing fMRI scan.
- Cognitive impairment and not being able to follow instruction.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ning Tang, PhD contact
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital
Singapore, 119228
Effie Chew, effie_chew@nuhs.edu.sg
Ning Tang, ning_tang@nuhs.edu.sg
- Recruiting
Alexandra Hospital
Singapore, 159964
Effie Chew, effie_chew@nuhs.edu.sg
Ning Tang, ning_tang@nuhs.edu.sg
About this study
This study aims to improve brain stimulation techniques for stroke patients dealing with motor and language issues. Researchers believe that current practices lack clarity because patients aren't grouped effectively and stimulation methods vary widely.
The study will include 250 participants from Alexandra Hospital and National University Hospital. Once someone is eligible and agrees to join, they'll first undergo a baseline assessment to evaluate their condition. After that, they'll receive non-invasive brain stimulation (NIBS) over the course of a month.
Read more
Participants will be assigned to specific NIBS treatments-either transcranial direct current stimulation (tDCS) or repetitive transcranial magnetic stimulation (rTMS)-based on their rehabilitation goals, medical history, and initial assessment results. Those needing to improve upper or lower limb movement, alleviate language difficulties (aphasia), or address neglect will receive tailored interventions: 20 sessions of tDCS or 12 sessions of rTMS.
After the treatment, participants will be assessed again immediately and then six weeks later to measure any changes in their condition.
Read the detailed description
This is a non-randomized study aimed to refine and confirm non-invasive brain stimulation (NIBS) protocols for motor and language deficits and stratification of stroke patients. The lack of stratification of patients and the variety of current stimulation protocols used has been suggested to have contributed to the lack of clarity in this area.
250 subjects will be recruited from Alexandra Hospital (AH) and National University Hospital (NUH). Once subject is identified to be eligible for the study and is agreeable to participate into the study, he/she will undergo the outcome measures of Baseline Assessment. After that, subject will receive NIBS intervention in the following 1 month.
The NIBS intervention that any subject is going to receive will be assigned by the medical doctors in the study team. The intervention allocation will be determined by:
- The main rehabilitation goal that the subject wishes to achieve, i.e., to improve upper limb mobility, to improve lower limb mobility, to alleviate aphasia, or to alleviate neglect;
- Medical history;
- Baseline function outcomes including motor function, TMS result, neglect and aphasia test result; The NIBS devices used in this study are tDCS (transcranial direct current stimulation) and rTMS (repetitive transcranial magnetic stimulation). 20 sessions of tDCS, or 12 sessions of rTMS will be conducted over 1 month for NIBS intervention.
The same outcome measures will be performed again after the last NIBS session (Post Assessment), and 6 weeks after the last NIBS session (Follow-up Assessment).
- Conditions
- Stroke
- Being tested
- noninvasive brain stimulation (NIBS) including transcranial direct current stimulation (tDCS) and repetitive TMS (rTMS)
- Keywords
- Stroke, rehabilitation, non-invasive brain stimulation, transcranial direct current stimulation, repetitive transcranial magnetic stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive brain stimulation (NIBS) including transcranial direct current stimulation (tDCS) and repetitive TMS (rTMS)Device
The NIBS devices used in this study are tDCS (1. Newronikia, Italy; 2. Magstim, UK) and DuoMag TMS (Deymed, Czech). All are commercialized in market. 20 sessions of tDCS, or 12 sessions of rTMS will be conducted over 1 month for NIBS intervention.
| Study group | Role | What they receive |
|---|---|---|
| non-invasive brain stimulation (NIBS) | Experimental | Subject will receive either 20 sessions of transcranial direct current stimulation (tDCS), or 12 sessions of repetitive transcranial magnetic stimulation (rTMS) in 30 days. Receives: Device: noninvasive brain stimulation (NIBS) including transcranial direct current stimulation (tDCS) and repetitive TMS (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Fugl-Meyer Assessment (UE-FMA)
UE-FMA is a standardized, performance-based impairment index used to evaluate motor recovery following a stroke. The score ranges from 0 to 66. Higher score indicates higher function.
Measured: Week 0
Upper Extremity Fugl-Meyer Assessment (UE-FMA)
UE-FMA is a standardized, performance-based impairment index used to evaluate motor recovery following a stroke. The score ranges from 0 to 66. Higher score indicates higher function.
Measured: after NIBS, up to 6 weeks
Upper Extremity Fugl-Meyer Assessment (UE-FMA)
UE-FMA is a standardized, performance-based impairment index used to evaluate motor recovery following a stroke. The score ranges from 0 to 66. Higher score indicates higher function.
Measured: follow-up, 6 weeks to 6 months after NIBS
Action Research Arm test (ARAT)
ARAT is a 19-item test used to evaluate upper extremity function, with scores ranging from a minimum of 0 to a maximum of 57. Higher scores on the ARAT indicate better functional performance, while lower scores indicate greater impairment.
Measured: Week 0
Action Research Arm test (ARAT)
ARAT is a 19-item test used to evaluate upper extremity function, with scores ranging from a minimum of 0 to a maximum of 57. Higher scores on the ARAT indicate better functional performance, while lower scores indicate greater impairment.
Measured: after NIBS, up to 6 weeks
Action Research Arm test (ARAT)
ARAT is a 19-item test used to evaluate upper extremity function, with scores ranging from a minimum of 0 to a maximum of 57. Higher scores on the ARAT indicate better functional performance, while lower scores indicate greater impairment.
Measured: follow-up, 6 weeks to 6 months after NIBS
peak-to-peak amplitude of motor evoked potential (MEP)
It is an indicator of cortical excitability, will be measured by TMS.
Measured: Week 0
peak-to-peak amplitude of motor evoked potential (MEP)
It is an indicator of cortical excitability, will be measured by TMS.
Measured: after NIBS, up to 6 weeks
peak-to-peak amplitude of motor evoked potential (MEP)
It is an indicator of cortical excitability, will be measured by TMS.
Measured: follow-up, 6 weeks to 6 months after NIBS
Secondary outcomes (36)
Modified Ashworth scale (MAS) of the affected muscles
Test for muscle spasticity, score ranges from 0 to 4, with higher score indicating worse outcome.
Measured: Week 0
Modified Ashworth scale (MAS) of the affected muscles
Test for muscle spasticity, score ranges from 0 to 4, with higher score indicating worse outcome.
Measured: after NIBS, up to 6 weeks
Modified Ashworth scale (MAS) of the affected muscles
Test for muscle spasticity, score ranges from 0 to 4, with higher score indicating worse outcome.
Measured: follow-up, 6 weeks to 6 months after NIBS
Coherence measured by HD-EEG
Coherence measures the consistency of phase and amplitude between two brain regions, indicating how effectively they are communicating. It is a primary indicator of functional connectivity:
Measured: Week 0
Coherence measured by HD-EEG
Coherence measures the consistency of phase and amplitude between two brain regions, indicating how effectively they are communicating. It is a primary indicator of functional connectivity:
Measured: after NIBS, up to 6 weeks
Coherence measured by HD-EEG
Coherence measures the consistency of phase and amplitude between two brain regions, indicating how effectively they are communicating. It is a primary indicator of functional connectivity:
Measured: follow-up, 6 weeks to 6 months after NIBS
Fractional Amplitude of Low-Frequency Fluctuations (fALFF)
Measured by fMRI. fALFF measures the intensity of spontaneous brain activity. It calculates the ratio of power in the low-frequency range (0.01-0.1 Hz) compared to the entire frequency spectrum.
Measured: Week 0
Fractional Amplitude of Low-Frequency Fluctuations (fALFF)
Measured by fMRI. fALFF measures the intensity of spontaneous brain activity. It calculates the ratio of power in the low-frequency range (0.01-0.1 Hz) compared to the entire frequency spectrum.
Measured: after NIBS, up to 6 weeks
Fractional Amplitude of Low-Frequency Fluctuations (fALFF)
Measured by fMRI. fALFF measures the intensity of spontaneous brain activity. It calculates the ratio of power in the low-frequency range (0.01-0.1 Hz) compared to the entire frequency spectrum.
Measured: follow-up, 6 weeks to 6 months after NIBS
Box and Block test
BBT measures unilateral gross manual dexterity by asking the user to move as many 1-inch wooden blocks as possible from one compartment to another over a partition in 60 seconds. It assesses the ability to grasp, transport, and release objects quickly, primarily used for patients with stroke or upper limb impairments.
Measured: Week 0
Box and Block test
BBT measures unilateral gross manual dexterity by asking the user to move as many 1-inch wooden blocks as possible from one compartment to another over a partition in 60 seconds. It assesses the ability to grasp, transport, and release objects quickly, primarily used for patients with stroke or upper limb impairments.
Measured: after NIBS, up to 6 weeks
Box and Block test
BBT measures unilateral gross manual dexterity by asking the user to move as many 1-inch wooden blocks as possible from one compartment to another over a partition in 60 seconds. It assesses the ability to grasp, transport, and release objects quickly, primarily used for patients with stroke or upper limb impairments.
Measured: follow-up, 6 weeks to 6 months after NIBS
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
The EQ-5D-5L is a standardized, self-reported questionnaire used to measure health-related quality of life (HRQoL) across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension scores from 1 to 5, with higher score indicating worse outcome.
Measured: Week 0
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
The EQ-5D-5L is a standardized, self-reported questionnaire used to measure health-related quality of life (HRQoL) across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension scores from 1 to 5, with higher score indicating worse outcome.
Measured: up to 6 weeks
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
The EQ-5D-5L is a standardized, self-reported questionnaire used to measure health-related quality of life (HRQoL) across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension scores from 1 to 5, with higher score indicating worse outcome.
Measured: follow-up, 6 weeks to 6 months after NIBS
Behavioral Inattention Test
The Behavioral Inattention Test (BIT) is a comprehensive, 40-minute paper-and-pencil screening tool used to assess unilateral visual neglect in stroke patients. It combines six conventional tests (e.g., line crossing) and nine daily-life behavioral tests (e.g., menu reading) to detect neglect in everyday situations, with a total score of 227. Higher score indicates better outcome.
Measured: Week 0
Behavioral Inattention Test
The Behavioral Inattention Test (BIT) is a comprehensive, 40-minute paper-and-pencil screening tool used to assess unilateral visual neglect in stroke patients. It combines six conventional tests (e.g., line crossing) and nine daily-life behavioral tests (e.g., menu reading) to detect neglect in everyday situations, with a total score of 227. Higher score indicates better outcome.
Measured: after NIBS, up to 6 weeks
Behavioral Inattention Test
The Behavioral Inattention Test (BIT) is a comprehensive, 40-minute paper-and-pencil screening tool used to assess unilateral visual neglect in stroke patients. It combines six conventional tests (e.g., line crossing) and nine daily-life behavioral tests (e.g., menu reading) to detect neglect in everyday situations, with a total score of 227. Higher score indicates better outcome.
Measured: follow-up, 6 weeks to 6 months after NIBS
Catherine Bergego Scale
A functional, observational assessment used to measure the presence and severity of unilateral spatial neglect (USN) in everyday life. The scale ranges from 0 to 30, with higher score indicating worse outcomes.
Measured: Week 0
Catherine Bergego Scale
A functional, observational assessment used to measure the presence and severity of unilateral spatial neglect (USN) in everyday life. The scale ranges from 0 to 30, with higher score indicating worse outcomes.
Measured: after NIBS, up to 6 weeks
Catherine Bergego Scale
A functional, observational assessment used to measure the presence and severity of unilateral spatial neglect (USN) in everyday life. The scale ranges from 0 to 30, with higher score indicating worse outcomes.
Measured: follow-up, 6 weeks to 6 months after NIBS
10 meter walk test
test for walking speed
Measured: Week 0
10 meter walk test
test for walking speed
Measured: after NIBS, up to 6 weeks
10 meter walk test
test for walking speed
Measured: follow-up, 6 weeks to 6 months after NIBS
Five Times Sit to Stand Test
The Five Times Sit to Stand Test (5xSTS) is a simple, standardized functional assessment used to measure lower extremity strength, transitional movement ability, and dynamic balance, primarily in older adults. It is commonly used to screen for fall risks and evaluate mobility in clinical settings.
Measured: Week 0
Five Times Sit to Stand Test
The Five Times Sit to Stand Test (5xSTS) is a simple, standardized functional assessment used to measure lower extremity strength, transitional movement ability, and dynamic balance, primarily in older adults. It is commonly used to screen for fall risks and evaluate mobility in clinical settings.
Measured: after NIBS, up to 6 weeks
Five Times Sit to Stand Test
The Five Times Sit to Stand Test (5xSTS) is a simple, standardized functional assessment used to measure lower extremity strength, transitional movement ability, and dynamic balance, primarily in older adults. It is commonly used to screen for fall risks and evaluate mobility in clinical settings.
Measured: follow-up, 6 weeks to 6 months after NIBS
Functional Ambulation Classification (FAC)
The Functional Ambulation Classification (FAC) is a 6-point ordinal scale used to evaluate functional walking ability based on the level of human assistance required. The score is ranged from 0 (Non-functional ambulator) to 5 (Independent ambulator). Higher scale indicates better outcomes.
Measured: Week 0
Functional Ambulation Classification (FAC)
The Functional Ambulation Classification (FAC) is a 6-point ordinal scale used to evaluate functional walking ability based on the level of human assistance required. The score is ranged from 0 (Non-functional ambulator) to 5 (Independent ambulator). Higher scale indicates better outcomes.
Measured: after NIBS, up to 6 weeks
Functional Ambulation Classification (FAC)
The Functional Ambulation Classification (FAC) is a 6-point ordinal scale used to evaluate functional walking ability based on the level of human assistance required. The score is ranged from 0 (Non-functional ambulator) to 5 (Independent ambulator). Higher scale indicates better outcomes.
Measured: follow-up, 6 weeks to 6 months after NIBS
AusTOMS (Australian Therapy Outcome Measures) for Speech Pathology
AusTOMS is a standardized, clinician-rated tool designed to measure the impact of speech pathology interventions in rehabilitation settings, including stroke recovery. It provides a quick "snapshot" (typically under 5 minutes) of a patient's status across four specific domains: Impairment, Activity Limitation, Participation Restriction, and Wellbeing. Score of each domain ranges from 0 to 5, a higher score indicates improvement or better functioning.
Measured: Week 0
AusTOMS (Australian Therapy Outcome Measures) for Speech Pathology
AusTOMS is a standardized, clinician-rated tool designed to measure the impact of speech pathology interventions in rehabilitation settings, including stroke recovery. It provides a quick "snapshot" (typically under 5 minutes) of a patient's status across four specific domains: Impairment, Activity Limitation, Participation Restriction, and Wellbeing. Score of each domain ranges from 0 to 5, a higher score indicates improvement or better functioning.
Measured: after NIBS, up to 6 weeks
AusTOMS (Australian Therapy Outcome Measures) for Speech Pathology
AusTOMS is a standardized, clinician-rated tool designed to measure the impact of speech pathology interventions in rehabilitation settings, including stroke recovery. It provides a quick "snapshot" (typically under 5 minutes) of a patient's status across four specific domains: Impairment, Activity Limitation, Participation Restriction, and Wellbeing. Score of each domain ranges from 0 to 5, a higher score indicates improvement or better functioning.
Measured: follow-up, 6 weeks to 6 months after NIBS
Western Aphasia Battery Revised (WAB-R) in English
WAB-R is a standardized diagnostic tool used by clinicians to assess the language and communication abilities of adults with acquired neurological disorders like stroke or head injury. It identifies the presence, type, and severity of aphasia. Range of score is 0 to 100. Higher score indicates better language function.
Measured: Week 0
Western Aphasia Battery Revised (WAB-R) in English
WAB-R is a standardized diagnostic tool used by clinicians to assess the language and communication abilities of adults with acquired neurological disorders like stroke or head injury. It identifies the presence, type, and severity of aphasia. Range of score is 0 to 100. Higher score indicates better language function.
Measured: after NIBS, up to 6 weeks
Western Aphasia Battery Revised (WAB-R) in English
WAB-R is a standardized diagnostic tool used by clinicians to assess the language and communication abilities of adults with acquired neurological disorders like stroke or head injury. It identifies the presence, type, and severity of aphasia. Range of score is 0 to 100. Higher score indicates better language function.
Measured: follow-up, 6 weeks to 6 months after NIBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start5 Aug 2024
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Effie Chew, Principal investigator, NUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786649
- Sponsor's protocol ID
- 2023/01014
- Other IDs
- 2023
- Status last verified
- Aug 2025
- First submitted
- 19 Feb 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to institution research policies, research agreement must be signed before sharing data with external parties.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Different Protocols of Non-invasive Brain Stimulation (NIBS) in Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT07786649
- Acronym / sponsor ID
- 2023/01014
- Conditions
- Stroke
- Keywords
- Stroke, rehabilitation, non-invasive brain stimulation, transcranial direct current stimulation, repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 26 Aug 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 aims to improve brain stimulation techniques for stroke patients dealing with motor and language issues. Researchers believe that current practices lack clarity because patients aren't grouped effectively and stimulation methods vary widely.
The study will include 250 participants from Alexandra Hospital and National University Hospital. Once someone is eligible and agrees to join, they'll first undergo a baseline assessment to evaluate their condition. After that, they'll receive non-invasive brain stimulation (NIBS) over the course of a month.
Participants will be assigned to specific NIBS treatments-either transcranial direct current stimulation (tDCS) or repetitive transcranial magnetic stimulation (rTMS)-based on their rehabilitation goals, medical history, and initial assessment results. Those needing to improve upper or lower limb movement, alleviate language difficulties (aphasia), or address neglect will receive tailored interventions: 20 sessions of tDCS or 12 sessions of rTMS.
After the treatment, participants will be assessed again immediately and then six weeks later to measure any changes in their condition.
Detailed description
This is a non-randomized study aimed to refine and confirm non-invasive brain stimulation (NIBS) protocols for motor and language deficits and stratification of stroke patients. The lack of stratification of patients and the variety of current stimulation protocols used has been suggested to have contributed to the lack of clarity in this area.
250 subjects will be recruited from Alexandra Hospital (AH) and National University Hospital (NUH). Once subject is identified to be eligible for the study and is agreeable to participate into the study, he/she will undergo the outcome measures of Baseline Assessment. After that, subject will receive NIBS intervention in the following 1 month.
The NIBS intervention that any subject is going to receive will be assigned by the medical doctors in the study team. The intervention allocation will be determined by:
- The main rehabilitation goal that the subject wishes to achieve, i.e., to improve upper limb mobility, to improve lower limb mobility, to alleviate aphasia, or to alleviate neglect;
- Medical history;
- Baseline function outcomes including motor function, TMS result, neglect and aphasia test result; The NIBS devices used in this study are tDCS (transcranial direct current stimulation) and rTMS (repetitive transcranial magnetic stimulation). 20 sessions of tDCS, or 12 sessions of rTMS will be conducted over 1 month for NIBS intervention.
The same outcome measures will be performed again after the last NIBS session (Post Assessment), and 6 weeks after the last NIBS session (Follow-up Assessment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-invasive brain stimulation (NIBS) | Experimental | Device: noninvasive brain stimulation (NIBS) including transcranial direct current stimulation (tDCS) and repetitive TMS (rTMS)Subject will receive either 20 sessions of transcranial direct current stimulation (tDCS), or 12 sessions of repetitive transcranial magnetic stimulation (rTMS) in 30 days. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21-80 years old;
- Diagnosis of stroke, with good premorbid function.
- Presenting with at least 1 of the following functional impairment:
- 3a. Upper limb motor impairment with the sum of Medical Research Council grades for shoulder abduction and finger Extension (SAFE) ≤ 8; 3b. Lower limb motor impairment with Functional Ambulation Classification (FAC) 0-3; 3c. Neglect as assessed by Behavioural Inattention Test with a cut-off of \<129 and Catherine Bergego Scale with a cut-off of \>5/30 3d. Expressive Aphasia as indicated by AusTOMS score of 1-4 (mild to severe) in the Language and Speech scales 4. Being able to follow instruction and give consent.
Key exclusion criteria (8 listed)
- Pregnancy;
- cardiac pacemakers;
- Sensorimotor disturbance due to other causes other than stroke;
- Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
- Major depression and a history of psychotic disorders;
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 |
|---|---|---|
| noninvasive brain stimulation (NIBS) including transcranial direct current stimulation (tDCS) and repetitive TMS (rTMS)The NIBS devices used in this study are tDCS (1. Newronikia, Italy; 2. Magstim, UK) and DuoMag TMS (Deymed, Czech). All are commercialized in market. 20 sessions of tDCS, or 12 sessions of rTMS will be conducted over 1 month for NIBS intervention. | Device | non-invasive brain stimulation (NIBS) |
Primary outcome
Upper Extremity Fugl-Meyer Assessment (UE-FMA)
Time frame: Week 0
UE-FMA is a standardized, performance-based impairment index used to evaluate motor recovery following a stroke. The score ranges from 0 to 66. Higher score indicates higher function.
Upper Extremity Fugl-Meyer Assessment (UE-FMA)
Time frame: after NIBS, up to 6 weeks
UE-FMA is a standardized, performance-based impairment index used to evaluate motor recovery following a stroke. The score ranges from 0 to 66. Higher score indicates higher function.
Upper Extremity Fugl-Meyer Assessment (UE-FMA)
Time frame: follow-up, 6 weeks to 6 months after NIBS
UE-FMA is a standardized, performance-based impairment index used to evaluate motor recovery following a stroke. The score ranges from 0 to 66. Higher score indicates higher function.
Action Research Arm test (ARAT)
Time frame: Week 0
ARAT is a 19-item test used to evaluate upper extremity function, with scores ranging from a minimum of 0 to a maximum of 57. Higher scores on the ARAT indicate better functional performance, while lower scores indicate greater impairment.
Action Research Arm test (ARAT)
Time frame: after NIBS, up to 6 weeks
ARAT is a 19-item test used to evaluate upper extremity function, with scores ranging from a minimum of 0 to a maximum of 57. Higher scores on the ARAT indicate better functional performance, while lower scores indicate greater impairment.
Action Research Arm test (ARAT)
Time frame: follow-up, 6 weeks to 6 months after NIBS
ARAT is a 19-item test used to evaluate upper extremity function, with scores ranging from a minimum of 0 to a maximum of 57. Higher scores on the ARAT indicate better functional performance, while lower scores indicate greater impairment.
peak-to-peak amplitude of motor evoked potential (MEP)
Time frame: Week 0
It is an indicator of cortical excitability, will be measured by TMS.
peak-to-peak amplitude of motor evoked potential (MEP)
Time frame: after NIBS, up to 6 weeks
It is an indicator of cortical excitability, will be measured by TMS.
peak-to-peak amplitude of motor evoked potential (MEP)
Time frame: follow-up, 6 weeks to 6 months after NIBS
It is an indicator of cortical excitability, will be measured by TMS.
36 secondary outcomes
Modified Ashworth scale (MAS) of the affected muscles
Time frame: Week 0
Modified Ashworth scale (MAS) of the affected muscles
Time frame: after NIBS, up to 6 weeks
Modified Ashworth scale (MAS) of the affected muscles
Time frame: follow-up, 6 weeks to 6 months after NIBS
Coherence measured by HD-EEG
Time frame: Week 0
Coherence measured by HD-EEG
Time frame: after NIBS, up to 6 weeks
Coherence measured by HD-EEG
Time frame: follow-up, 6 weeks to 6 months after NIBS
Fractional Amplitude of Low-Frequency Fluctuations (fALFF)
Time frame: Week 0
Fractional Amplitude of Low-Frequency Fluctuations (fALFF)
Time frame: after NIBS, up to 6 weeks
Fractional Amplitude of Low-Frequency Fluctuations (fALFF)
Time frame: follow-up, 6 weeks to 6 months after NIBS
Box and Block test
Time frame: Week 0
Box and Block test
Time frame: after NIBS, up to 6 weeks
Box and Block test
Time frame: follow-up, 6 weeks to 6 months after NIBS
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
Time frame: Week 0
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
Time frame: up to 6 weeks
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
Time frame: follow-up, 6 weeks to 6 months after NIBS
Behavioral Inattention Test
Time frame: Week 0
Behavioral Inattention Test
Time frame: after NIBS, up to 6 weeks
Behavioral Inattention Test
Time frame: follow-up, 6 weeks to 6 months after NIBS
Catherine Bergego Scale
Time frame: Week 0
Catherine Bergego Scale
Time frame: after NIBS, up to 6 weeks
Catherine Bergego Scale
Time frame: follow-up, 6 weeks to 6 months after NIBS
10 meter walk test
Time frame: Week 0
10 meter walk test
Time frame: after NIBS, up to 6 weeks
10 meter walk test
Time frame: follow-up, 6 weeks to 6 months after NIBS
Five Times Sit to Stand Test
Time frame: Week 0
Five Times Sit to Stand Test
Time frame: after NIBS, up to 6 weeks
Five Times Sit to Stand Test
Time frame: follow-up, 6 weeks to 6 months after NIBS
Functional Ambulation Classification (FAC)
Time frame: Week 0
Functional Ambulation Classification (FAC)
Time frame: after NIBS, up to 6 weeks
Functional Ambulation Classification (FAC)
Time frame: follow-up, 6 weeks to 6 months after NIBS
AusTOMS (Australian Therapy Outcome Measures) for Speech Pathology
Time frame: Week 0
AusTOMS (Australian Therapy Outcome Measures) for Speech Pathology
Time frame: after NIBS, up to 6 weeks
AusTOMS (Australian Therapy Outcome Measures) for Speech Pathology
Time frame: follow-up, 6 weeks to 6 months after NIBS
Western Aphasia Battery Revised (WAB-R) in English
Time frame: Week 0
Western Aphasia Battery Revised (WAB-R) in English
Time frame: after NIBS, up to 6 weeks
Western Aphasia Battery Revised (WAB-R) in English
Time frame: follow-up, 6 weeks to 6 months after NIBS
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 26 Aug 2026.
- Individual participant dataSharing planned: No. According to institution research policies, research agreement must be signed before sharing data with external parties.
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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.
Ning Tang, PhD contact
Effie Chew principal investigator
NUH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noninvasive brain stimulation (NIBS) including transcranial direct current stimulation (tDCS) and repetitive TMS (rTMS) in people with Stroke, run by National University Hospital, Singapore at 2 sites 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 4 inclusion and 8 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 26 Aug 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 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. 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 Effie Chew, MBBS (65-64722000, effie_chew@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Extremity Fugl-Meyer Assessment (UE-FMA) (time frame: Week 0). The study lists 9 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 26 Aug 2026.