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

National Taiwan University

Status

Enrolling

Conditions

Focused Ultrasound

Stroke

Treatments

Device: NaviFUS® Neuronavigation-guided focused ultrasound system

Study type

Interventional

Funder types

Other

Identifiers

NCT06391086

202305124DIPB

Details and patient eligibility

About

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.

Full description

The study is a pilot study for feasibility, which aims to recruit 20 patients with subacute (within 3 months) stroke and unilateral hemiparesis. tFUS stimulation will be delivered. The primary outcomes are defined as cortical excitability assessment in bilateral primary motor cortex, as well as safety analysis; the secondary outcome measures include the Fugl-Meyer Assessment, Medical Research Council score, National Institutes of Health Stroke Scale (NIHSS), Barthel Index, Modified Rankin Scale and functional brain activities.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.