Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Dystonic Tremor: a Prospective, Randomized, Double-blinded, Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 5 months
研究概览
简要总结
The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of dystonic tremor (DT) in a randomized, double-blinded, cross-over manner.
详细描述
This is a randomized, double-blinded, crossover trial aiming at comparing the efficacy of PSA and STN DBS in treating dystonic tremor. Enrolled patients will undergo bilateral DBS surgery, targeting both PSA and STN with single trajectory. Three months post-implantation, patients enter a 4-month double-blinded crossover phase with PSA and STN DBS in randomized order. After 7 months post-implantation (at the end of the crossover phase), patients enter an open-label phase during which programming parameters are not restricted until the termination of the study at 12-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with dystonic tremor based on the MDS 2018 consensus
- •Duration of DT symptoms: ≥3 years of motor symptoms
- •If the patient is taking tremor medications, the medications should be stable for 28 days prior to informed consent
- •Good compliance and written informed consent
排除标准
- •Any intracranial abnormalities that would prevent DBS surgery
- •Any significant mental illness that might affect the subject's ability to comply with the study protocol requirements (e.g., bipolar disorder, schizophrenia, mood disorders with psychotic features, Cluster B personality disorders)
- •Severe cognitive impairment, MOCA score <24
- •Any current substance or alcohol abuse according to DSM-V criteria
- •Any history of recurrent or unprovoked epileptic seizures; any prior movement disorder treatment involving intracranial surgery or device implantation; any history of hemorrhagic stroke; any significant medical condition that might interfere with the study procedures or could confound the assessment of study endpoints
- •Any terminal illness with a life expectancy of <1 year
研究组 & 干预措施
PSA-STN
Participants randomized in this arm will receive bilateral PSA stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral STN stimulation for another two months.
干预措施: Deep brain stimulation (Device)
STN-PSA
Participants randomized in this arm will receive bilateral STN stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral PSA stimulation for another two months.
干预措施: Deep brain stimulation (Device)
结局指标
主要结局
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 5 months
时间窗: 5 months
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 7 months
时间窗: 7 months
次要结局
- Change from baseline Beck depression inventory to 5 months(5 months)
- Change from baseline Beck depression inventory to 7 months(7 months)
- Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 7 months(7 months)
- Change from baseline Mini-Mental Status Exam to 5 months(5 months)
- Change from baseline Mini-Mental Status Exam to 7 months(7 months)
- Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 5 months(5 months)
- Adverse events(up to 12 months after surgery)