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RECRUITING

NCT06391086

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

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-08-01

Completion Date

2029-10-01

Last Updated

2026-04-06

Healthy Volunteers

Conditions

Focused Ultrasound Stroke

Interventions

DEVICE

NaviFUS® Neuronavigation-guided focused ultrasound system

The treatment protocol consists of once daily treatment for consecutive five tFUS sessions.

DEVICE

NaviFUS® Neuronavigation-guided focused ultrasound system

No ultrasound energy will be delivered (Mechanical Index, MI = 0); only the background music will be played (During each treatment session, the background music will be presented in the same way as in the experimental group during the operation of the focused ultrasound system). All other stimulation settings and procedures will be identical to those used in the experimental group

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan