Gentle electrical brain stimulation (anodal tDCS) to help arm recovery after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, blinded, sham-controlled trial using the Soterix Medical 1x1 tDCS stimulator to deliver either real or sham anodal stimulation to the unaffected hemisphere. Fifty hospitalized patients with subacute unilateral stroke and severe upper limb weakness (within 8 weeks of onset, SAFE score <5) will be randomized 1:1 to active or sham tDCS. The team will measure clinical efficacy, technical feasibility, and safety of the intervention during inpatient rehabilitation. The trial is conducted at Tan Tock Seng Hospital Integrated Care Hub with standard rehabilitation care provided to all participants.

Why it matters

Who can join: the full rules

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

Where it's running

• Tan Tock Seng Hospital - Integrated Care Hub
  Singapore, Singapore, Singapore Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.