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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: National University Hospital, Singapore • ClinicalTrials.gov ID: NCT07786649

Registry updated: 2026-08-26
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Description

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.

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.

Eligibility criteria

Inclusion Criteria: 1. Age 21-80 years old; 2. Diagnosis of stroke, with good premorbid function. 3. 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: 1. Pregnancy; 2. cardiac pacemakers; 3. Sensorimotor disturbance due to other causes other than stroke; 4. Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina; 5. Major depression and a history of psychotic disorders; 6. Terminal diagnosis with life expectancy \<=1 year; 7. Claustrophobia for those undergoing fMRI scan. 8. Cognitive impairment and not being able to follow instruction.

Conditions

Stroke

Locations

  • National University Hospital — Singapore, Singapore
  • Alexandra Hospital — Singapore, Singapore
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record