NCT06391086 Neuromodulation Effect of Focused Ultrasound for Motor Recovery in Patients With Stroke
| NCT ID | NCT06391086 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Focused Ultrasound |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2029-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-08-01 with a primary completion date of 2029-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Meng Ting Lin, M.D.
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT06391086 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Focused Ultrasound. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06391086 currently recruiting?
Yes, NCT06391086 is actively recruiting participants. Contact the research team at b96401093@ntu.edu.tw for enrollment information.
Where is the NCT06391086 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06391086 clinical trial?
NCT06391086 is sponsored by National Taiwan University Hospital. The principal investigator is Meng Ting Lin, M.D. at National Taiwan University Hospital. The trial plans to enroll 50 participants.