Use of Anodal tDCS to Enhance Upper Limb Recovery in Stroke

Tan Tock Seng Hospital50 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Stroke

Interventions

Anodal tDCSDEVICE

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

Sham tDCSDEVICE

Sham tDCS is applied

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Tan Tock Seng Hospital - Integrated Care Hub

Singapore, Singapore, Singapore

RECRUITING

Outcomes

Primary Outcomes

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

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)

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)

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)

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.

Data from ClinicalTrials.gov

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