Actively Recruiting
Modulate Tremor Severity With Low-intensity Focused Ultrasound Stimulation Targeting the Deep Nucleus of Patients With Refractory Hand Tremor.
Led by National Taiwan University Hospital · Updated on 2025-09-15
12
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Modulate Tremor Severity With Low-intensity Focused Ultrasound Stimulation Targeting the Deep Nucleus of Patients With Refractory Hand Tremor.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years.
- Diagnosis of Parkinson's disease tremor, essential tremor, or dystonic tremor with inadequate response to medication.
- Willingness to shave hair over the treatment area for focused ultrasound.
- Stable medication types and dosages for at least 4 weeks prior to enrollment.
- Normal liver and kidney function (Creatinine < 1.3 mg/dL, GPT < 41 U/L).
- Agreement to use appropriate contraception from first treatment until 6 months after last treatment if of childbearing potential or having partners of childbearing potential.
You will not qualify if you...
- Presence of intracranial implants unsuitable for MRI, such as metal clips, ventriculoperitoneal shunts, cochlear implants, DBS devices, pacemakers, or ICDs.
- Abnormalities along the ultrasound beam path including scars, scalp conditions, wounds, atrophy, or calcification.
- Pregnant or breastfeeding women.
- Use of other investigational drugs.
- Major depressive disorder with Beck Depression Inventory-II score > 30 in past year or suicidal thoughts.
- Conditions interfering with treatment or increasing risk as judged by investigator.
- Brain tumors, vascular malformations, or significant traumatic brain injury.
- Significant psychiatric symptoms (Clinical Dementia Rating of 2 or higher).
- Use of anticoagulant medications or medications that worsen tremor.
- Tremor caused by metabolic or psychogenic reasons.
- Coagulation disorders or abnormal coagulation test results.
- Inability to consent or comply with study procedures.
- Insufficient skull density for ultrasound transmission (<20%).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Hsinchu City, Taiwan, 300
Actively Recruiting
Research Team
K
Kai-Hsiang Kai-Hsiang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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