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

NCT06391086 | Recruiting

• 1 other identifier: 202305124DIPB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Focused Ultrasound

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-related Adverse Events

  Includes rate of minor (scalp pain, headache, short-term dizziness, nausea, vomiting, short-term weakness, short-term numbness) and severe adverse events (seizure, persistent new onset weakness, documented new intracranial hemorrhage or infarction, death)

  Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.

• Cortical excitability

  The amplitude and latency of maximal MEP, rMT in bilateral primary motor cortex will be assessed.

  Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.

Secondary Outcomes (6)

• Fugl-Meyer Assessment-Upper Extremity

  Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.

• Medical Research Council score

  Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.

• National Institutes of Health Stroke Scale (NIHSS)

  Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.

• Barthel Index

  Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.

• Modified Rankin Scale

  Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.

Study Arms (2)

Treatment with tFUS

EXPERIMENTAL

Treatment with tFUS

Device: NaviFUS® Neuronavigation-guided focused ultrasound system

Control

SHAM COMPARATOR

No ultrasound energy, only the background music will be played.

Device: NaviFUS® Neuronavigation-guided focused ultrasound system

Interventions

NaviFUS® Neuronavigation-guided focused ultrasound system DEVICE

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

Treatment with tFUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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;

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Meng Ting Lin, M.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng Ting Lin, M.D.

CONTACT

+886-2312-3456; b96401093@ntu.edu.tw

Ming Yen Hsiao, M.D.

CONTACT

+886-2312-3456; myferrant@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)