Sound waves aimed at the brain could boost stroke recovery
NCT ID NCT06391086
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether low-intensity focused ultrasound, a non-invasive technique, can help stroke patients regain arm and hand movement. Fifty adults who had a stroke within the past three months and have some arm weakness will receive either real or sham ultrasound daily for five days. Researchers will check for side effects and measure changes in brain activity and motor function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NaviFUS® Neuronavigation-guided focused ultrasound system (device)
- What this could lead to
- If it works, this could offer a non-invasive way to improve arm and hand movement after a stroke, without surgery or drugs.
- What could go wrong
- This is a small, early-stage study focused on safety and brain activity, not yet proven to improve recovery. The effect may be small or not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Taiwan University Hospital
RECRUITINGTaipei, Taiwan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Moving patterns may help stroke survivors read faster
- Vibrating wearables put stroke walking to the test
- Robot plus electrical stimulation aims to rebuild arm movement after stroke
- Can a checklist and heart monitor stop repeat strokes?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next