Use of Anodal tDCS to Enhance Upper Limb Recovery in Stroke

NCT07151729 | Recruiting FDA Device

• 1 other identifier: DSRB 2024-4011
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; tdcs; upper limb

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• 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)

  At baseline (Day 0) At end of 10 tDCS sessions (Day 10)

• EQ5D-5L

  At baseline (Day 0) and at 3 months after the 10th tDCS session (Month 3)

• Rate of Adverse Events from tDCS

  Immediately after each tDCS session (total 10 sessions of tDCS)

Study Arms (2)

Anodal tDCS

EXPERIMENTAL

Anodal tDCS to contralateral dorsal premotor cortex (dPMc)

Device: Anodal tDCS

Sham tDCS

SHAM COMPARATOR

Sham tDCS to contralateral dorsal premotor cortex (dPMc)

Device: Sham tDCS

Interventions

Anodal tDCS DEVICE

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

Also known as: tDCS

Anodal tDCS

Sham tDCS DEVICE

Sham tDCS is applied

Also known as: tdcs

Sham tDCS

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Ng Teng Fong Healthcare Innovation Programme: collaborator

Study Sites (1)

Tan Tock Seng Hospital - Integrated Care Hub

Singapore, Singapore, 307382, Singapore

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial 1 control group (with sham transcranial direct current stimulation) and 1 intervention group (with real anodal transcranial direct current stimulation)

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: September 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)