Using focused ultrasound to help stroke recovery

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

This study is testing if a special type of ultrasound can help people who had a stroke in the last three months recover better and improve their movement.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (other)
• Locations: 1 site (Taipei)
• Trial ID: NCT06391086 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the effects of transcranial focused ultrasound (tFUS) on motor recovery in patients who have experienced a stroke within the last three months. The study will recruit 20 patients with unilateral hemiparesis and assess cortical excitability in the primary motor cortex following tFUS stimulation. Primary outcomes include safety analysis and cortical excitability, while secondary outcomes will evaluate motor function and overall recovery using various clinical scales. The intervention utilizes the NaviFUS® neuronavigation-guided focused ultrasound system.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older who have had a stroke within the last three months and exhibit upper limb muscle weakness.

Not a fit: Patients with a history of recurrent strokes, neurodegenerative diseases, or contraindications to focused ultrasound may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance motor recovery in stroke patients, potentially improving their quality of life.

How similar studies have performed: While focused ultrasound is a novel approach in this context, preliminary studies have shown promise in neuromodulation effects, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)

Study contacts

• Principal investigator: Meng Ting Lin, M.D. — National Taiwan University Hospital
• Study coordinator: Meng Ting Lin, M.D.

Conditions: Focused Ultrasound, Stroke