Parkinson Disease (PD)NCT07172295
Modulate Tremor Severity With Low-intensity Focused Ultrasound Stimulation Targeting the Deep Nucleus of Patients With Refractory Hand Tremor.
A study testing Accelerated NaviFUS-ctbFUS stimulation in people with Parkinson Disease (PD) and Essential Tremor, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The study plans to recruit 12 patients with Parkinsonian tremor, essential tremor, or dystonic tremor. After receiving NaviFUS-ctbTUS stimulation, the improvement in their tremor will be recorded. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease (PD), Essential Tremor, Dystonic Tremor
- What is being tested?
- Accelerated NaviFUS-ctbFUS stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jun 2025to 31 Dec 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years.
- Subjects must belong to one of the following three categories:
- Patients with Parkinson's disease tremor who have an inadequate response to medication.
- Patients with essential tremor who have an inadequate response to medication.
- Patients with dystonic tremor who have an inadequate response to medication.
- Subjects are willing to shave hair over the treatment area for focused ultrasound.
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- Stable medication regimen (types and dosages) for at least 4 weeks prior to study enrollment.
- Normal liver and renal function (Creatinine < 1.3 mg/dL, GPT < 41 U/L).
- Female participants of childbearing potential, or male participants with female partners of childbearing potential, must agree to use appropriate contraception from the first study treatment until at least 6 months after the last treatment to prevent pregnancy.
Who cannot join
- Presence of intracranial implants deemed unsuitable for MRI, such as metal clips, ventriculoperitoneal (VP) shunts, cochlear implants, deep brain stimulation (DBS) devices, pacemakers, or implantable cardioverter- defibrillators (ICDs).
- Any abnormalities along the focused ultrasound beam path through the skull, including scars on the skull, scalp conditions (e.g., eczema), open wounds, calp atrophy, or significant calcification confirmed by imaging along the ultrasound transmission pathway.
- Pregnant or breastfeeding women.
- Use of investigational drugs from other clinical trials.
- Patients with major depressive disorder (Beck Depression Inventory-II score > 30 within the past year) or with suicidal ideation.
- Any condition that, in the opinion of the investigator, may interfere with treatment efficacy or increase risk to the subject.
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- Presence of any brain tumors, vascular malformations, or significant traumatic brain injury.
- Presence of significant psychiatric symptoms (Clinical Dementia Rating [CDR]
- 2).
- Use of anticoagulant medications.
- Use of medications known to exacerbate tremor.
- Tremor due to metabolic or psychogenic causes.
- Coagulopathy or abnormal coagulation profiles, including any of the following:
- Platelet count ≤ 100,000/µL
- INR ≥ 1.5
- PT ≥ 1.5 × upper limit of normal (ULN)
- aPTT ≥ 1.5 × ULN
- Fibrinogen ≤ 150 mg/dL
- Inability to provide informed consent or comply with study procedures, posing potential safety concerns.
- Insufficient skull density as determined by pre-treatment evaluation, resulting in ultrasound transmission efficiency less than 20%.
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 Hsin-Chu Branch
Hsinchu, Hsinchu City, 300
Kai-Hsiang Chen, M.D., +886-3-5326151 ext. 522610, stanleychen1230@gmail.com
About this study
The study plans to recruit 12 patients with Parkinsonian tremor, essential tremor, or dystonic tremor. After receiving NaviFUS-ctbTUS stimulation, the improvement in their tremor will be recorded.
- Conditions
- Parkinson Disease (PD), Essential Tremor, Dystonic Tremor, Continuous Theta Burst Stimulation Transcranial Focused Ultrasound
- Being tested
- Accelerated NaviFUS-ctbFUS stimulation
- Keywords
- NaviFUS, Tremor, Transcranial focused ultrasound
- Medical subject headings
- Parkinson Disease, Essential Tremor, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated NaviFUS-ctbFUS stimulationProcedure or surgery
Three consecutive sessions of NaviFUS-ctbTUS stimulation were performed, with a 5-minute interval between each session.
The acoustic pressure was set such that the estimated intracranial pressure at 30% skull transmission was approximately 0.5 MPa.
The stimulation target was the center of the Vop, with a total of 7 stimulation points.
| Study group | Role | What they receive |
|---|---|---|
| Tremor treatment | Experimental | Not described Receives: Procedure: Accelerated NaviFUS-ctbFUS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events Compared to Baseline [Safety Assessment]
The safety of using the NaviFUS system in patients with tremor will be assessed throughout the study period. Any examination result that shows a significant change compared to baseline (Visit 1), as determined by the investigator, will be documented and reported as an adverse event (AE).
Measured: Day of first stimulation, 7 days after first stimulation, day of second stimulation, 7 days after second stimulation, and 28 days after second stimulation.
Secondary outcomes (1)
Change in Tremor Amplitude [Efficacy]
Efficacy will be assessed by determining whether there is a change in tremor amplitude across multiple time points following treatment. Measurements (archimedes spirogram ) will be taken pre-treatment and at several time points post-treatment to evaluate immediate and short-term effects.
Measured: On the day of first stimulation and the day of second stimulation: immediately before treatment, and at 0, 20, 40, and 60 minutes post-treatment; on the day of second stimulation, also after task-based fMRI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start11 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172295
- Sponsor's protocol ID
- 202405134DINC
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulate Tremor Severity With Low-intensity Focused Ultrasound Stimulation Targeting the Deep Nucleus of Patients With Refractory Hand Tremor.
- ClinicalTrials.gov ID
- NCT07172295
- Acronym / sponsor ID
- 202405134DINC
- Conditions
- Parkinson Disease (PD), Essential Tremor, Dystonic Tremor, Continuous Theta Burst Stimulation Transcranial Focused Ultrasound
- Keywords
- NaviFUS, Tremor, Transcranial focused ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Sep 2025 (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.
The study plans to recruit 12 patients with Parkinsonian tremor, essential tremor, or dystonic tremor. After receiving NaviFUS-ctbTUS stimulation, the improvement in their tremor will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tremor treatment | Experimental | Procedure: Accelerated NaviFUS-ctbFUS stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 80 years.
- Subjects must belong to one of the following three categories:
- Subjects are willing to shave hair over the treatment area for focused ultrasound.
- Stable medication regimen (types and dosages) for at least 4 weeks prior to study enrollment.
- Normal liver and renal function (Creatinine < 1.3 mg/dL, GPT < 41 U/L).
Key exclusion criteria (20 listed)
- Presence of intracranial implants deemed unsuitable for MRI, such as metal clips, ventriculoperitoneal (VP) shunts, cochlear implants, deep brain stimulation (DBS) devices, pacemakers, or implantable cardioverter- defibrillators (ICDs).
- Any abnormalities along the focused ultrasound beam path through the skull, including scars on the skull, scalp conditions (e.g., eczema), open wounds, calp atrophy, or significant calcification confirmed by imaging along the ultrasound transmission pathway.
- Pregnant or breastfeeding women.
- Use of investigational drugs from other clinical trials.
- Patients with major depressive disorder (Beck Depression Inventory-II score > 30 within the past year) or with suicidal ideation.
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 |
|---|---|---|
| Accelerated NaviFUS-ctbFUS stimulationThree consecutive sessions of NaviFUS-ctbTUS stimulation were performed, with a 5-minute interval between each session. The acoustic pressure was set such that the estimated intracranial pressure at 30% skull transmission was approximately 0.5 MPa. The stimulation target was the center of the Vop, with a total of 7 stimulation points. | Procedure or surgery | Tremor treatment |
Primary outcome
Incidence of Adverse Events Compared to Baseline [Safety Assessment]
Time frame: Day of first stimulation, 7 days after first stimulation, day of second stimulation, 7 days after second stimulation, and 28 days after second stimulation.
The safety of using the NaviFUS system in patients with tremor will be assessed throughout the study period. Any examination result that shows a significant change compared to baseline (Visit 1), as determined by the investigator, will be documented and reported as an adverse event (AE).
1 secondary outcome
Change in Tremor Amplitude [Efficacy]
Time frame: On the day of first stimulation and the day of second stimulation: immediately before treatment, and at 0, 20, 40, and 60 minutes post-treatment; on the day of second stimulation, also after task-based fMRI.
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 15 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated NaviFUS-ctbFUS stimulation in people with Parkinson Disease (PD) and Essential Tremor, 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 9 inclusion and 20 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 15 Sep 2025. 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. 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 Kai-Hsiang Kai-Hsiang, M.D. (+886-3-5326151, stanleychen1230@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events Compared to Baseline [Safety Assessment] (time frame: Day of first stimulation, 7 days after first stimulation, day of second stimulation, 7 days after second stimulation, and 28 days after second stimulation.). 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 15 Sep 2025.