Use of Anodal tDCS to Enhance Upper Limb Recovery in Stroke

Tan Tock Seng Hospital

Status: Enrolling

Conditions: Stroke

Treatments: Device: Anodal tDCS; Device: Sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT07151729

DSRB 2024-4011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Anodal tDCS

Experimental group

Description:

Anodal tDCS to contralateral dorsal premotor cortex (dPMc)

Treatment:

Device: Anodal tDCS

Sham tDCS

Sham Comparator group

Description:

Sham tDCS to contralateral dorsal premotor cortex (dPMc)

Treatment:

Device: Sham tDCS