About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 21-80 years old;
Diagnosis of stroke, with good premorbid function.
Disqualifiers
Pregnancy;
cardiac pacemakers;
Sensorimotor disturbance due to other causes other than stroke;
Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
Trial design
Single group
Treatments tested in this trial
noninvasive brain stimulation (NIBS) including transcranial direct current stimulation (tDCS) and repetitive TMS (rTMS)
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Modified Ashworth scale (MAS) of the affected muscles
Test for muscle spasticity, score ranges from 0 to 4, with higher score indicating worse outcome.
Modified Ashworth scale (MAS) of the affected muscles
Test for muscle spasticity, score ranges from 0 to 4, with higher score indicating worse outcome.
Modified Ashworth scale (MAS) of the affected muscles
Test for muscle spasticity, score ranges from 0 to 4, with higher score indicating worse outcome.
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:
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