Stroke
Conditions
Keywords
Stroke, rehabilitation, non-invasive brain stimulation, transcranial direct current stimulation, repetitive transcranial magnetic stimulation
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.
Detailed description
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).
Interventions
DEVICEnoninvasive brain stimulation (NIBS) including transcranial direct current stimulation (tDCS) and repetitive TMS (rTMS)
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.
Sponsors
National University Hospital, Singapore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm test (ARAT) | Week 0 | 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. |
| peak-to-peak amplitude of motor evoked potential (MEP) | Week 0 | It is an indicator of cortical excitability, will be measured by TMS. |
| Upper Extremity Fugl-Meyer Assessment (UE-FMA) | Week 0 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coherence measured by HD-EEG | Week 0 | 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: |
| Fractional Amplitude of Low-Frequency Fluctuations (fALFF) | Week 0 | Measured by fMRI. fALFF measures the intensity of spontaneous brain activity. It calculates the ratio of power in the low-frequency range (0.01-0.1 Hz) compared to the entire frequency spectrum. |
| Behavioral Inattention Test | Week 0 | The Behavioral Inattention Test (BIT) is a comprehensive, 40-minute paper-and-pencil screening tool used to assess unilateral visual neglect in stroke patients. It combines six conventional tests (e.g., line crossing) and nine daily-life behavioral tests (e.g., menu reading) to detect neglect in everyday situations, with a total score of 227. Higher score indicates better outcome. |
| Catherine Bergego Scale | Week 0 | A functional, observational assessment used to measure the presence and severity of unilateral spatial neglect (USN) in everyday life. The scale ranges from 0 to 30, with higher score indicating worse outcomes. |
| 10 meter walk test | Week 0 | test for walking speed |
| Five Times Sit to Stand Test | Week 0 | The Five Times Sit to Stand Test (5xSTS) is a simple, standardized functional assessment used to measure lower extremity strength, transitional movement ability, and dynamic balance, primarily in older adults. It is commonly used to screen for fall risks and evaluate mobility in clinical settings. |
| Functional Ambulation Classification (FAC) | Week 0 | The Functional Ambulation Classification (FAC) is a 6-point ordinal scale used to evaluate functional walking ability based on the level of human assistance required. The score is ranged from 0 (Non-functional ambulator) to 5 (Independent ambulator). Higher scale indicates better outcomes. |
| AusTOMS (Australian Therapy Outcome Measures) for Speech Pathology | Week 0 | AusTOMS is a standardized, clinician-rated tool designed to measure the impact of speech pathology interventions in rehabilitation settings, including stroke recovery. It provides a quick "snapshot" (typically under 5 minutes) of a patient's status across four specific domains: Impairment, Activity Limitation, Participation Restriction, and Wellbeing. Score of each domain ranges from 0 to 5, a higher score indicates improvement or better functioning. |
| Box and Block test | Week 0 | BBT measures unilateral gross manual dexterity by asking the user to move as many 1-inch wooden blocks as possible from one compartment to another over a partition in 60 seconds. It assesses the ability to grasp, transport, and release objects quickly, primarily used for patients with stroke or upper limb impairments. |
| Western Aphasia Battery Revised (WAB-R) in English | Week 0 | WAB-R is a standardized diagnostic tool used by clinicians to assess the language and communication abilities of adults with acquired neurological disorders like stroke or head injury. It identifies the presence, type, and severity of aphasia. Range of score is 0 to 100. Higher score indicates better language function. |
| EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) | Week 0 | The EQ-5D-5L is a standardized, self-reported questionnaire used to measure health-related quality of life (HRQoL) across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension scores from 1 to 5, with higher score indicating worse outcome. |
| Modified Ashworth scale (MAS) of the affected muscles | Week 0 | Test for muscle spasticity, score ranges from 0 to 4, with higher score indicating worse outcome. |
Countries
Singapore
Contacts
CONTACTEffie Chew, MBBS
CONTACTNing Tang, PhD
PRINCIPAL_INVESTIGATOREffie Chew
NUH
Outcome results
None listed