NCT07786649 Evaluating Different Protocols of Non-invasive Brain Stimulation (NIBS) in Stroke Rehabilitation
| NCT ID | NCT07786649 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University Hospital, Singapore |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-08-05 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2024-08-05 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Effie Chew
PRINCIPAL INVESTIGATOR
NUH
Frequently Asked Questions
Who can join the NCT07786649 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07786649 currently recruiting?
Yes, NCT07786649 is actively recruiting participants. Contact the research team at effie_chew@nuhs.edu.sg for enrollment information.
Where is the NCT07786649 trial being conducted?
This trial is being conducted at Singapore, Singapore, Singapore, Singapore.
Who is sponsoring the NCT07786649 clinical trial?
NCT07786649 is sponsored by National University Hospital, Singapore. The principal investigator is Effie Chew at NUH. The trial plans to enroll 250 participants.
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