Phase
Condition
Stroke
Cerebral Ischemia
Treatment
NaviFUS® Neuronavigation-guided focused ultrasound system
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
National Taiwan University Hospital
Taipei,
TaiwanActive - Recruiting
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