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

Last updated: August 18, 2024
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

NaviFUS® Neuronavigation-guided focused ultrasound system

Clinical Study ID

NCT06391086
202305124DIPB
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with stroke (including hemorrhagic or ischemic stroke) diagnosed by aboard-certificated physician.

  • Occurrence of stroke within three months.

  • Upper limb muscle strength ≤ 4 points according to the Medical Research CouncilManual Muscle Testing scale.

  • No previous history of stroke, epilepsy, dementia, Parkinson's disease, or otherneurodegenerative diseases.

  • Patients could maintain sitting posture for more than 15 minutes on a chair.

  • 18 years of age or older.

Exclusion

Exclusion Criteria:

  • History of recurrent stroke, traumatic brain injuries, brain tumors, spinal cordinjury, Parkinson's disease or other musculoskeletal system diseases that may affectevaluation and treatment.

  • Contraindications to focused ultrasound, including pregnancy, cardiac pacemaker orimplantable medical device, abnormal connective tissue diseases, coagulopathy (PLT<100,000/μL, PT>14 seconds, APTT>36 seconds, INR>1.3), implants near or in thebrain, or those deemed Unsuitable for this treatment by the physician.

  • Unable to cooperate with treatment or functional assessment due to impairedconsciousness 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, brainsurgery, 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.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: NaviFUS® Neuronavigation-guided focused ultrasound system
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
October 01, 2029

Study 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.

Connect with a study center

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Active - Recruiting

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