About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Anodal tDCS
- Sham tDCS
Treatment groups
Sponsors and collaborators
Tan Tock Seng Hospital
Lead sponsor
Ng Teng Fong Healthcare Innovation Programme
Collaborator