Focused UltrasoundNCT06391086
Neuromodulation Effect of Focused Ultrasound for Motor Recovery in Patients With Stroke
A study testing NaviFUS® Neuronavigation-guided focused ultrasound system in people with Focused Ultrasound and Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focused Ultrasound, Stroke
- What is being tested?
- NaviFUS® Neuronavigation-guided focused ultrasound system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2024to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Meng Ting Lin, M.D., +886-2312-3456 ext. 67048, mntinglin@ntuh.gov.tw
About this study
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.
Read the detailed description
The study is a pilot study for feasibility, which aims to recruit 20 patients with subacute (within 3 months) stroke and unilateral hemiparesis. tFUS stimulation will be delivered to the primary motor cortex on the healthy side. The treatment protocol consists of once daily treatment for consecutive five tFUS sessions. The primary outcomes are defined as cortical excitability assessment in bilateral primary motor cortex, as well as safety analysis; the secondary outcome measures include the Fugl-Meyer Assessment, Medical Research Council score, National Institutes of Health Stroke Scale (NIHSS), Barthel Index, Modified Rankin Scale and functional brain activities. The evaluation will be conducted before treatment and on the first day, first week, fourth week, and twelfth week after completing tFUS.
The second part of this study is an efficacy investigation, which plans to recruit 30 subacute stroke patients for a randomized controlled trial with a parallel-group design. The experimental group will receive focused ultrasound stimulation with the same parameters and target site as the Phase I pilot study, while the control group will receive sham stimulation at the same location. The treatment frequency will be the same as that of the pilot study.
- Conditions
- Focused Ultrasound, Stroke
- Being tested
- NaviFUS® Neuronavigation-guided focused ultrasound system
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaviFUS® Neuronavigation-guided focused ultrasound systemDevice
The treatment protocol consists of once daily treatment for consecutive five tFUS sessions.
NaviFUS® Neuronavigation-guided focused ultrasound systemDevice
No ultrasound energy will be delivered (Mechanical Index, MI = 0); only the background music will be played (During each treatment session, the background music will be presented in the same way as in the experimental group during the operation of the focused ultrasound system). All other stimulation settings and procedures will be identical to those used in the experimental group
| Study group | Role | What they receive |
|---|---|---|
| Treatment with tFUS | Experimental | Treatment with tFUS Receives: Device: NaviFUS® Neuronavigation-guided focused ultrasound system |
| Control | Sham comparator | No ultrasound energy, only the background music will be played. Receives: Device: NaviFUS® Neuronavigation-guided focused ultrasound system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-related Adverse Events
Includes rate of minor (scalp pain, headache, short-term dizziness, nausea, vomiting, short-term weakness, short-term numbness) and severe adverse events (seizure, persistent new onset weakness, documented new intracranial hemorrhage or infarction, death)
Measured: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
Cortical excitability
The amplitude and latency of maximal MEP, rMT in bilateral primary motor cortex will be assessed.
Measured: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
Secondary outcomes (6)
Fugl-Meyer Assessment-Upper Extremity
The Fugl-Meyer Assessment for upper extremity is a standardized tool used to assess motor recovery after stroke. It consists of four items: shoulder/elbow/forearm, wrist, hand, and coordination. Each item is scored individually, with scores ranging from 0 to 2 depending on the quality of the movement. The total score ranges from 0 to 66, with higher scores indicating better motor function and recovery.
Measured: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
Medical Research Council score
The Medical Research Council (MRC) score is a simple and widely used scale to assess muscle strength. It rates muscle strength on a scale from 0 to 5, with 0 being no muscle contraction and 5 being normal muscle strength.
Measured: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
National Institutes of Health Stroke Scale (NIHSS)
The National Institutes of Health Stroke Scale (NIHSS) is a standardized tool used to assess the severity of a stroke and its effects on patients. It evaluates various neurological functions, such as consciousness, movement, sensation, and language, assigning scores ranging from 0 to 42, with higher scores indicating more severe stroke symptoms.
Measured: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
Barthel Index
The Barthel Index is a measure of a person's ability to perform activities of daily living. It assesses functions such as feeding, bathing, grooming, dressing, bowel and bladder control, toileting, transfers, mobility, and stairs. The score ranges from 0 to 100, with higher scores indicating greater independence.
Measured: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
Modified Rankin Scale
The Modified Rankin Scale is a widely used tool to assess a patient's level of disability after a stroke or other neurological disorders. It measures the degree of disability or dependence in daily activities, with scores ranging from 0 (no symptoms) to 6 (death).
Measured: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
Functional brain activities
Functional brain activities were detected by fNIRS (NIRSport2 NIRx Medical Technologies LLC, Glen Head, NY, USA). The subjects were requested to perform functional task (unilateral hand grasping), and brain activities was recorded by fNIRS in the following brain regions: bilateral premotor cortices, supplementary motor area, M1 and primary somatosensory cortices. The ΔHbO2 signal will be analyzed using the HOMER2 fNIRS analysis software.
Measured: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Aug 2024
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focused UltrasoundStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng Ting Lin, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391086
- Sponsor's protocol ID
- 202305124DIPB
- Status last verified
- Mar 2026
- First submitted
- 25 Apr 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation Effect of Focused Ultrasound for Motor Recovery in Patients With Stroke
- ClinicalTrials.gov ID
- NCT06391086
- Acronym / sponsor ID
- 202305124DIPB
- Conditions
- Focused Ultrasound, Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a pilot study for feasibility, which aims to recruit 20 patients with subacute (within 3 months) stroke and unilateral hemiparesis. tFUS stimulation will be delivered to the primary motor cortex on the healthy side. The treatment protocol consists of once daily treatment for consecutive five tFUS sessions. The primary outcomes are defined as cortical excitability assessment in bilateral primary motor cortex, as well as safety analysis; the secondary outcome measures include the Fugl-Meyer Assessment, Medical Research Council score, National Institutes of Health Stroke Scale (NIHSS), Barthel Index, Modified Rankin Scale and functional brain activities. The evaluation will be conducted before treatment and on the first day, first week, fourth week, and twelfth week after completing tFUS.
The second part of this study is an efficacy investigation, which plans to recruit 30 subacute stroke patients for a randomized controlled trial with a parallel-group design. The experimental group will receive focused ultrasound stimulation with the same parameters and target site as the Phase I pilot study, while the control group will receive sham stimulation at the same location. The treatment frequency will be the same as that of the pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with tFUS | Experimental | Device: NaviFUS® Neuronavigation-guided focused ultrasound systemTreatment with tFUS |
| Control | Sham comparator | Device: NaviFUS® Neuronavigation-guided focused ultrasound systemNo ultrasound energy, only the background music will be played. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaviFUS® Neuronavigation-guided focused ultrasound systemThe treatment protocol consists of once daily treatment for consecutive five tFUS sessions. | Device | Treatment with tFUS |
| NaviFUS® Neuronavigation-guided focused ultrasound systemNo ultrasound energy will be delivered (Mechanical Index, MI = 0); only the background music will be played (During each treatment session, the background music will be presented in the same way as in the experimental group during the operation of the focused ultrasound system). All other stimulation settings and procedures will be identical to those used in the experimental group | Device | Control |
Primary outcome
Incidence of Treatment-related Adverse Events
Time frame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
Includes rate of minor (scalp pain, headache, short-term dizziness, nausea, vomiting, short-term weakness, short-term numbness) and severe adverse events (seizure, persistent new onset weakness, documented new intracranial hemorrhage or infarction, death)
Cortical excitability
Time frame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
The amplitude and latency of maximal MEP, rMT in bilateral primary motor cortex will be assessed.
6 secondary outcomes
Fugl-Meyer Assessment-Upper Extremity
Time frame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
Medical Research Council score
Time frame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
National Institutes of Health Stroke Scale (NIHSS)
Time frame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
Barthel Index
Time frame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
Modified Rankin Scale
Time frame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
Functional brain activities
Time frame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meng Ting Lin, M.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaviFUS® Neuronavigation-guided focused ultrasound system in people with Focused Ultrasound and Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng Ting Lin, M.D. (+886-2312-3456 ext. 67048, b96401093@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-related Adverse Events (time frame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.