Modulate Tremor Severity With Low-intensity Focused Ultrasound Stimulation Targeting the Deep Nucleus of Patients With Refractory Hand Tremor.

NCT07172295 | Recruiting

• 1 other identifier: 202405134DINC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Continuous Theta Burst Stimulation Transcranial Focused Ultrasound; Parkinson Disease (PD); Essential Tremor; Dystonic Tremor

Keywords

NaviFUS; Tremor; Transcranial focused ultrasound

Outcome Measures

Primary Outcomes (1)

• 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).

  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]

  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.

Study Arms (1)

Tremor treatment

EXPERIMENTAL

Procedure: Accelerated NaviFUS-ctbFUS stimulation

Interventions

Accelerated NaviFUS-ctbFUS stimulation PROCEDURE

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.

Tremor treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Presence of any brain tumors, vascular malformations, or significant traumatic brain injury.
• Presence of significant psychiatric symptoms (Clinical Dementia Rating \[CDR\]
• 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)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Hsinchu City, 300, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor; Tremor

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kai-Hsiang Kai-Hsiang, M.D.

CONTACT

+886-3-5326151; stanleychen1230@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Taiwan University Hospital

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: September 15, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-08

Locations

TW (1)