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NCT Number: NCT07786649

Evaluating Different Protocols of Non-invasive Brain Stimulation (NIBS) in Stroke Rehabilitation

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandra Hospital, Singapore

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. Modified Ashworth scale (MAS) of the affected muscles

    Time frame: Week 0

    Test for muscle spasticity, score ranges from 0 to 4, with higher score indicating worse outcome.

  2. Modified Ashworth scale (MAS) of the affected muscles

    Time frame: after NIBS, up to 6 weeks

    Test for muscle spasticity, score ranges from 0 to 4, with higher score indicating worse outcome.

  3. Modified Ashworth scale (MAS) of the affected muscles

    Time frame: follow-up, 6 weeks to 6 months after NIBS

    Test for muscle spasticity, score ranges from 0 to 4, with higher score indicating worse outcome.

  4. Coherence measured by HD-EEG

    Time frame: Week 0

    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:

  5. Coherence measured by HD-EEG

    Time frame: after NIBS, up to 6 weeks

    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:

  6. Coherence measured by HD-EEG

    Time frame: follow-up, 6 weeks to 6 months after NIBS

    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:

  7. Fractional Amplitude of Low-Frequency Fluctuations (fALFF)

    Time frame: Week 0

    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.

  8. Fractional Amplitude of Low-Frequency Fluctuations (fALFF)

    Time frame: after NIBS, up to 6 weeks

    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.

  9. Fractional Amplitude of Low-Frequency Fluctuations (fALFF)

    Time frame: follow-up, 6 weeks to 6 months after NIBS

    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.

  10. Box and Block test

    Time frame: Week 0

    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.

  11. Box and Block test

    Time frame: after NIBS, up to 6 weeks

    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.

  12. Box and Block test

    Time frame: follow-up, 6 weeks to 6 months after NIBS

    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.

  13. EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)

    Time frame: Week 0

    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.

  14. EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)

    Time frame: up to 6 weeks

    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.

  15. EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)

    Time frame: follow-up, 6 weeks to 6 months after NIBS

    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.

  16. Behavioral Inattention Test

    Time frame: Week 0

    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.

  17. Behavioral Inattention Test

    Time frame: after NIBS, up to 6 weeks

    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.

  18. Behavioral Inattention Test

    Time frame: follow-up, 6 weeks to 6 months after NIBS

    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.

  19. Catherine Bergego Scale

    Time frame: Week 0

    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.

  20. Catherine Bergego Scale

    Time frame: after NIBS, up to 6 weeks

    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.

  21. Catherine Bergego Scale

    Time frame: follow-up, 6 weeks to 6 months after NIBS

    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.

  22. 10 meter walk test

    Time frame: Week 0

    test for walking speed

  23. 10 meter walk test

    Time frame: after NIBS, up to 6 weeks

    test for walking speed

  24. 10 meter walk test

    Time frame: follow-up, 6 weeks to 6 months after NIBS

    test for walking speed

  25. Five Times Sit to Stand Test

    Time frame: Week 0

    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.

  26. Five Times Sit to Stand Test

    Time frame: after NIBS, up to 6 weeks

    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.

  27. Five Times Sit to Stand Test

    Time frame: follow-up, 6 weeks to 6 months after NIBS

    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.

  28. Functional Ambulation Classification (FAC)

    Time frame: Week 0

    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.

  29. Functional Ambulation Classification (FAC)

    Time frame: after NIBS, up to 6 weeks

    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.

  30. Functional Ambulation Classification (FAC)

    Time frame: follow-up, 6 weeks to 6 months after NIBS

    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.

  31. AusTOMS (Australian Therapy Outcome Measures) for Speech Pathology

    Time frame: Week 0

    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.

  32. AusTOMS (Australian Therapy Outcome Measures) for Speech Pathology

    Time frame: after NIBS, up to 6 weeks

    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.

  33. AusTOMS (Australian Therapy Outcome Measures) for Speech Pathology

    Time frame: follow-up, 6 weeks to 6 months after NIBS

    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.

  34. Western Aphasia Battery Revised (WAB-R) in English

    Time frame: Week 0

    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.

  35. Western Aphasia Battery Revised (WAB-R) in English

    Time frame: after NIBS, up to 6 weeks

    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.

  36. Western Aphasia Battery Revised (WAB-R) in English

    Time frame: follow-up, 6 weeks to 6 months after NIBS

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Effie Chew, MBBS

CONTACT

[email protected]

65-64722000

Ning Tang, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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