NCT07172295招募中不适用
Modulate Tremor Severity With Low-intensity Focused Ultrasound Stimulation Targeting the Deep Nucleus of Patients With Refractory Hand Tremor.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Events Compared to Baseline [Safety Assessment]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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%.
结局指标
主要结局
Incidence of Adverse Events Compared to Baseline [Safety Assessment]
时间窗: 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).
次要结局
- 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.)
研究者
National Taiwan University Clinical Trial Center
National Taiwan University Hospital
National Taiwan University Hospital
研究点 (2)
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