Use of Anodal tDCS to Enhance Upper Limb Recovery in Stroke

NCT ID: NCT07151729

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Anodal tDCS

Anodal tDCS to contralateral dorsal premotor cortex (dPMc)

Group Type: EXPERIMENTAL

Anodal tDCS

Intervention Type: DEVICE

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

Sham tDCS

Sham tDCS to contralateral dorsal premotor cortex (dPMc)

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

Sham tDCS is applied

Interventions

Anodal tDCS

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

Intervention Type: DEVICE

Sham tDCS

Sham tDCS is applied

Intervention Type: DEVICE

Other Intervention Names

tDCS; 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ng Teng Fong Healthcare Innovation Programme

UNKNOWN

Sponsor Role: collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tan Tock Seng Hospital - Integrated Care Hub

Singapore, Singapore, Singapore

Site Status: RECRUITING

Countries

Singapore

Facility Contacts

WAI PING ALFRED SENG, MBBS, MRCP

Role: primary

alfred_seng@ttsh.com.sg

+65 68894580

Other Identifiers

DSRB 2024-4011

Identifier Type: -

Identifier Source: org_study_id