Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The incidence and nature of treatment-related adverse events
研究概览
简要总结
This objective of this study is to document the safety and feasibility of electrical stimulation of the deep cerebellar nuclei for refractory tremor using the Medtronic Percept RC Deep Brain Stimulation System. The population will consist of patients that have either failed a prior intervention (Vim DBS or HIFU thalamotomy) or determined to not be suitable candidates for Vim DBS or HIFU thalamotomy because they have a cerebellar outflow or MS-related tremor. Those patients with a previous intervention, must have a prior diagnosis of ET, cerebellar outflow tremor, or MS-related tremor. Subjects without a previous intervention must have a diagnosis of cerebellar outflow tremor or MS-related tremor.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years and older;
- •Ability to give informed consent;
- •Diagnosis of ET, cerebellar tremor, or MS-related tremor with a failed a prior intervention (VIM DBS or HIFU thalamotomy) or determined to not be suitable candidates for VIM DBS or HIFU thalamotomy because they have a cerebellar outflow or MS-related tremor.
- •Tremor history of at least three years;
- •Tremor that is refractory to medical management;
- •A score of ≥24 on the Mini Mental State Examination;
- •Inability to successfully perform ADLs without assistance or has lost interest in social, professional, or personal activities due to tremor
排除标准
- •Any other neurological condition that could reduce the safety of study participation including central nervous system vasculitis and intracranial malignancy
- •A condition that, in the opinion of the clinical investigator, would significantly increase the risk or interfere with study compliance, safety, or outcome;
- •A diagnosis of dementia;
- •Tremors due to other neurological conditions such as Parkinson's disease, dystonia, or other conditions not consistent with ET, cerebellar outflow tremor, or MS-related tremor.
- •Diagnosis of epilepsy;
- •Major active and untreated psychiatric illness that may interfere with study, such as psychotic disorders or severe personality disorders;
- •Untreated or inadequately treated depression defined by a score of 20 or greater on the Beck Depression Inventory-II at the time of enrollment;
- •At risk for suicide defined by a score greater or equal to 3 on the Columbia Suicide Severity Rating Scale (C-SSRS);
- •Pregnancy;
- •Unable to communicate with investigators or staff;
- •Surgical contraindications to DN DBS;
- •Contraindication to magnetic resonance (MRI) imaging, e.g., weight incompatible with scanner, implanted metallic devices or electrical devices (pacemaker, defibrillator, spinal cord stimulator, prior DBS) or intolerance to MRI contrast agent;
- •Enrolled in another device, biologic or pharmaceutical study within 30 days of consent in the current study, (i.e., patient cannot be enrolled if participation in another study was not completed at least 30 days prior to consent.);
- •Evidence of behavior(s) consistent with alcohol or substance abuse/dependence as defined by the criteria outlined in the DSM-V within the preceding six months;
- •Injection of botulinum toxins into the arm, neck or face within six months prior to baseline;
研究组 & 干预措施
Refractory Tremor
Medtronic Percept RC DBS System
干预措施: Deep Brain Stimulation (Device)
结局指标
主要结局
The incidence and nature of treatment-related adverse events
时间窗: From DBS Implant Surgery through study completion, an average of 17 months
The accumulation of adverse events across all subjects
次要结局
- 4-8 HZ (theta) tremor related oscillations(From DBS Implant Surgery through study completion, an average of 17 months)
- DBS-evoked potentials(From DBS Implant Surgery through study completion, an average of 17 months)
- Fahn Tolosa Marin Tremor Rating Scale(From DBS Implant Surgery through study completion, an average of 17 months)
研究者
Andre Machado
Institute Chief Neurological Institute
The Cleveland Clinic