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| Name | Class |
|---|---|
| Ng Teng Fong Healthcare Innovation Programme | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anodal tDCS | Experimental | Anodal tDCS to contralateral dorsal premotor cortex (dPMc) |
|
| Sham tDCS | Sham Comparator | Sham tDCS to contralateral dorsal premotor cortex (dPMc) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anodal tDCS | Device | This anodal tDCS is applied over the contralateral dorsal premotor cortex (instead of the ipsilateral motor cortex in previous studies). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Upper Limb | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Streamlined Wolf Motor Function Test (sWMFT) | 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) |
| Functional Independence Measure (FIM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tan Tock Seng Hospital - Integrated Care Hub | Recruiting | Singapore | Singapore | 307382 | Singapore |
To protect the privacy of participants. Preparing IPD for sharing can also be time-consuming and resource-intensive.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Randomised controlled trial
1 control group (with sham transcranial direct current stimulation) and 1 intervention group (with real anodal transcranial direct current stimulation)
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| Sham tDCS | Device | Sham tDCS is applied |
|
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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.
| At baseline (Day 0) At end of 10 tDCS sessions (Day 10) |
| 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. | At baseline (Day 0) and at 3 months after the 10th tDCS session (Month 3) |
| 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. | Immediately after each tDCS session (total 10 sessions of tDCS) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |