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Recruiting NCT07151729

Use of Anodal tDCS to Enhance Upper Limb Recovery in Stroke

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anodal tDCS, Sham tDCS.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 21 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Use of Anodal Transcranial Direct Current Stimulation to Enhance Upper Limb Recovery in Stroke

Overview

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

  • Device Anodal tDCS
    This anodal tDCS is applied over the contralateral dorsal premotor cortex (instead of the ipsilateral motor cortex in previous studies).
  • Device Sham tDCS
    Sham tDCS is applied

Primary outcome measures

  • 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 outcome measures (4)
  • 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)]
  • Functional Independence Measure (FIM) [Time frame: At baseline (Day 0) At end of 10 tDCS sessions (Day 10)]
  • EQ5D-5L [Time frame: At baseline (Day 0) and at 3 months after the 10th tDCS session (Month 3)]
  • Rate of Adverse Events from tDCS [Time frame: Immediately after each tDCS session (total 10 sessions of tDCS)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Singapore · 1 center
  • Tan Tock Seng Hospital - Integrated Care Hub — Singapore

Identifiers

NCT: NCT07151729 · DSRB 2024-4011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗