Use of Anodal tDCS to Enhance Upper Limb Recovery in Stroke
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorTan Tock Seng Hospital
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Anodal tDCS
DeviceThis anodal tDCS is applied over the contralateral dorsal premotor cortex (instead of the ipsilateral motor cortex in previous studies).
Sham tDCS
DeviceSham tDCS is applied
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Anodal tDCSExperimental treatment 1 intervention
Group B: Sham tDCSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fugl-Meyer Upper Limb
Fugl-Meyer Upper Limb
Time frame
At baseline (Day 0) At end of 10 tDCS sessions (Day 10) At 3 months after the 10th tDCS session (Month 3)Secondary outcomes
1
Streamlined Wolf Motor Function Test (sWMFT)
Streamlined Wolf Motor Function Test (sWMFT)
Time frame
At baseline (Day 0) At end of 10 tDCS sessions (Day 10) At 3 months after the 10th tDCS session (Month 3)2
Functional Independence Measure (FIM)
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.
Time frame
At baseline (Day 0) At end of 10 tDCS sessions (Day 10)3
EQ5D-5L
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.
Time frame
At baseline (Day 0) and at 3 months after the 10th tDCS session (Month 3)4
Rate of Adverse Events from 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.
Time frame
Immediately after each tDCS session (total 10 sessions of tDCS)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tan Tock Seng Hospital
Lead sponsor
Ng Teng Fong Healthcare Innovation Programme
Collaborator
Source ClinicalTrials.gov