Neuromodulation Effect of Focused Ultrasound for Motor Recovery in Patients With Stroke

Recruiting now · Not applicable

Conditions studied: Focused Ultrasound, Stroke

In brief

Transcranial focused ultrasound (tFUS) can be used as a non-invasive brain neuromodulation technique. Low-intensity focused ultrasound has been demonstrated to be safe and have neuromodulatory effects on the cerebral cortex in healthy human and animal experiments.This study aims to investigate the effect of tFUS on cortical excitability for motor recovery in patients with stroke.

Key facts

Study ID

NCT06391086

Run by

National Taiwan University Hospital

People needed

50

Starts

2024-08-01

Expected to finish

2029-10-01

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with stroke (including hemorrhagic or ischemic stroke) diagnosed by a board-certificated physician.
• Occurrence of stroke within three months.
• Upper limb muscle strength ≤ 4 points according to the Medical Research Council Manual Muscle Testing scale.
• No previous history of stroke, epilepsy, dementia, Parkinson's disease, or other neurodegenerative diseases.
• Patients could maintain sitting posture for more than 15 minutes on a chair.
• 18 years of age or older.

You may not qualify if…

• History of recurrent stroke, traumatic brain injuries, brain tumors, spinal cord injury, Parkinson's disease or other musculoskeletal system diseases that may affect evaluation and treatment.
• Contraindications to focused ultrasound, including pregnancy, cardiac pacemaker or implantable medical device, abnormal connective tissue diseases, coagulopathy (PLT<100,000/μL, PT>14 seconds, APTT>36 seconds, INR>1.3), implants near or in the brain, or those deemed Unsuitable for this treatment by the physician.
• Unable to cooperate with treatment or functional assessment due to impaired consciousness or aphasia; inability to informed consent.
• Patient with cranial bone factor causing the inability of tFUS penetration.
• Patient under anticoagulants with coagulopathy (PLT<100,000/μL, PT>14 seconds, APTT>36 seconds, INR>1.3)
• Patients who are not suitable for undergoing CT imaging examination;
• Major physical illnesses and neurological disorders (such as epilepsy, brain surgery, etc.)
• Patients with metallic implants in their bodies;
• Patients taking tricyclic antidepressants, analgesics, or using antiepileptic drugs
• Individuals experiencing sleep disorders during tFUS treatment;
• Individuals with history of alcoholism
• Patients with severe or uncontrollable intracranial pressure;
• Patients requiring anticoagulants;
• Any intracranial space-occupying lesions;
• Significant calcification of intracranial vessels based on pre-treatment CT imaging;
• Subjects with lesions/wounds on the scalp in the target region.

Where it is running

• National Taiwan University Hospital — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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