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

NCT07786649 | Recruiting DMC

• 2 other identifiers: 2023/010142023
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Stroke

Keywords

Stroke; rehabilitation; non-invasive brain stimulation; transcranial direct current stimulation; repetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  Week 0

• peak-to-peak amplitude of motor evoked potential (MEP)

  It is an indicator of cortical excitability, will be measured by TMS.

  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.

  follow-up, 6 weeks to 6 months after NIBS

Secondary Outcomes (36)

• Modified Ashworth scale (MAS) of the affected muscles

  Week 0

• Modified Ashworth scale (MAS) of the affected muscles

  after NIBS, up to 6 weeks

• Modified Ashworth scale (MAS) of the affected muscles

  follow-up, 6 weeks to 6 months after NIBS

• Coherence measured by HD-EEG

  Week 0

• Coherence measured by HD-EEG

  after NIBS, up to 6 weeks

Study Arms (1)

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.

Device: noninvasive brain stimulation (NIBS) including transcranial direct current stimulation (tDCS) and repetitive TMS (rTMS)

Interventions

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.

non-invasive brain stimulation (NIBS)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-80 years old;
• Diagnosis of stroke, with good premorbid function.
• Presenting with at least 1 of the following functional impairment:
• a. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (2)

National University Hospital

Singapore, 119228, Singapore

RECRUITING

Alexandra Hospital

Singapore, 159964, Singapore

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Effie Chew

  NUH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Effie Chew, MBBS

CONTACT

65-64722000; effie_chew@nuhs.edu.sg

Ning Tang, PhD

CONTACT

ning_tang@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: August 26, 2026
• Study Start: August 5, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: August 26, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)