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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2029-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Focused Ultrasound Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with tFUS

Group Type EXPERIMENTAL

NaviFUS® Neuronavigation-guided focused ultrasound system

Intervention Type DEVICE

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

Interventions

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NaviFUS® Neuronavigation-guided focused ultrasound system

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No