Stroke
Conditions
Keywords
stroke, tdcs, upper limb
Brief summary
This will be a randomized, blinded, sham-controlled trial. The medical device used, Soterix Medical 1x1 tDCS stimulator, is capable of delivering either real or sham tDCS and has been used in many randomised controlled trials in stroke patients. 50 patients with subacute stroke and severe upper limb weakness within 8 weeks of stroke on transfer to TTSH stroke rehab wards will be recruited over a period of 10 months. Recruited patients will be randomized into the intervention and control arms in a 1:1 ratio.
Detailed description
The primary objective is to determine the clinical efficacy, technical feasibility and safety of anodal tDCS therapy to the unaffected hemisphere in hospitalized subacute stroke patients with severe arm weakness.
Interventions
DEVICEAnodal tDCS
This anodal tDCS is applied over the contralateral dorsal premotor cortex (instead of the ipsilateral motor cortex in previous studies).
DEVICESham tDCS
Sham tDCS is applied
Sponsors
Ng Teng Fong Healthcare Innovation Programme
Tan Tock Seng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Randomised controlled trial 1 control group (with sham transcranial direct current stimulation) and 1 intervention group (with real anodal transcranial direct current stimulation)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* First ever unilateral ischaemic or haemorrhagic stroke, as documented by CT or MRI scans * Age 21-80 years, both males and females * Within 8 weeks of stroke onset * Severe weakness of one upper limb, defined by a Shoulder Abduction and Finger Extension (SAFE) score \< 5 (Medical Research Council grading) * Provision of informed consent by patient or a legal guardian in accordance with the local ethics committee guidelines and the Declaration of Helsinki
Exclusion criteria
* Bilateral hemispheric or cerebellar strokes * Pre-existing arm pathology (e.g. contracture, severe pain, etc.) on the affected side * Presence of brain implants, and previous insertion of external ventricular drains. * Metallic implants at the level of the neck, mouth cavity and below are permitted (e.g. Cardiac stents, dental implants, pacemakers and other metallic objects) * A history of spontaneous seizures, epilepsy, brain tumour, and cranial surgery * Severe cognitive impairment (MOCA Score \<10) that would hinder sufficient understanding of the instructions * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Upper Limb | At baseline (Day 0) At end of 10 tDCS sessions (Day 10) At 3 months after the 10th tDCS session (Month 3) | Fugl-Meyer Upper Limb |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Streamlined Wolf Motor Function Test (sWMFT) | At baseline (Day 0) At end of 10 tDCS sessions (Day 10) At 3 months after the 10th tDCS session (Month 3) | Streamlined Wolf Motor Function Test (sWMFT) |
| Functional Independence Measure (FIM) | At baseline (Day 0) At end of 10 tDCS sessions (Day 10) | Functional Independence Measure (FIM) is a widely used objective assessment tool in rehabilitation to evaluate a patient's functional abilities and track their progress. It is a 18-item, 7-level scale, with higher scores indicating greater independence. The total FIM score ranges from 18 to 126. |
| EQ5D-5L | At baseline (Day 0) and at 3 months after the 10th tDCS session (Month 3) | The EurolQol 5-Dimension 5-Level (EQ5D-5L) is a widely-used, non-disease specific questionnaire designed to assess a patient's health related quality of life. It serves as a patient-reported outcome instrument, capturing the patient's own perspective on their health. It consists of a descriptive system of five questions (each scored from Level 1 to 5, with a higher score indicating more severe problems) and a visual analogue scale (VAS) for overall health assessment. A higher VAS (from 0 to 100) would indicate a better quality of life. |
| Rate of Adverse Events from tDCS | Immediately after each tDCS session (total 10 sessions of tDCS) | An adverse events questionnaire is administered immediately after each tDCS session. As such, each participant would fill up 10 adverse effects questionnaires after a total of 10 tDCS sessions. The rate of adverse events from tDCS would be computed from the number of adverse events divided by the total number of tDCS sessions. |
Countries
Singapore
Outcome results
None listed