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

NCT ID: NCT07172295

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-11
• Study Completion Date: 2027-12-31

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tremor treatment

Group Type: EXPERIMENTAL

Accelerated NaviFUS-ctbFUS stimulation

Intervention Type: 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.

Interventions

Accelerated NaviFUS-ctbFUS stimulation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 80 years.
• Subjects must belong to one of the following three categories:

1. Patients with Parkinson's disease tremor who have an inadequate response to medication.

2. Patients with essential tremor who have an inadequate response to medication.

3. 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.

Exclusion Criteria

• 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]

• 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:

1. Platelet count ≤ 100,000/µL

2. INR ≥ 1.5

3. PT ≥ 1.5 × upper limit of normal (ULN)

4. aPTT ≥ 1.5 × ULN

5. 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%.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Clinical Trial Center

National Taiwan University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Hsinchu City, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Kai-Hsiang Kai-Hsiang, M.D.

Role: CONTACT

stanleychen1230@gmail.com

+886-3-5326151

Facility Contacts

Kai-Hsiang Chen, M.D.

Role: primary

stanleychen1230@gmail.com

+886-3-5326151 ext. 522610

Other Identifiers

202405134DINC

Identifier Type: -

Identifier Source: org_study_id