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New treatment option for Focused Ultrasound
Official title Neuromodulation Effect of Focused Ultrasound for Motor Recovery in Patients With Stroke
ClinicalTrials.gov ID: NCT06391086
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- History of recurrent stroke, traumatic brain injuries, brain tumors, spinal cord injury, Parkinson's disease or other musculoskeletal system diseases...
- Contraindications to focused ultrasound, including pregnancy, cardiac pacemaker or implantable medical device, abnormal connective tissue diseases...
- 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\ 14 seconds, APTT\>36 seconds, INR\>1.3)
- Patients who are not suitable for undergoing CT imaging examination;
See the full eligibility 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.
- 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\ 14 seconds, APTT\>36 seconds, INR\>1.3), implants...
- 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\ 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;
- people with lesions/wounds on the scalp in the target region.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.