Neuromodulation Effect of Focused Ultrasound for Motor Recovery in Patients With Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- NaviFUS® Neuronavigation-guided focused ultrasound system
- NaviFUS® Neuronavigation-guided focused ultrasound system
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov