Gentle electrical brain stimulation (anodal tDCS) to help arm recovery after stroke
Use of Anodal Transcranial Direct Current Stimulation to Enhance Upper Limb Recovery in Stroke
NA · Tan Tock Seng Hospital · NCT07151729
This trial will test whether anodal transcranial direct current stimulation (tDCS) applied to the unaffected side of the brain helps people with recent severe arm weakness after stroke recover better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Tan Tock Seng Hospital (other) |
| Locations | 1 site (Singapore, Singapore) |
| Trial ID | NCT07151729 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 21–80 with a first unilateral ischaemic or haemorrhagic stroke within 8 weeks and severe weakness of one upper limb (SAFE score <5) who can provide informed consent or have a legal guardian are eligible.
Not a fit: Patients with bilateral or cerebellar strokes, prior seizures, significant brain surgery or implants, severe cognitive impairment, or pre-existing arm pathology are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could speed or improve recovery of arm movement in people with severe weakness after subacute stroke.
How similar studies have performed: Anodal tDCS has been used in multiple randomized trials in stroke rehabilitation and has shown promising but mixed benefits in improving motor recovery.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Singapore, Singapore
- Tan Tock Seng Hospital - Integrated Care Hub — Singapore, Singapore, Singapore (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, stroke, tdcs, upper limb