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

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.

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:

1. 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;
2. Medical history;
3. 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).

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.