Evaluation of Directional Stimulation During the Implantation of Deep Brain Stimulation Leads for the Treatment of Movement Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Measurement of the therapeutic window's boundaries when stimulating in specific angular directions, and comparison to those obtained when stimulating in all directions.
研究概览
简要总结
The purpose of this study is to provide proof-of-concept that directional stimulation, in an intraoperative setting, is perceivable in a subject and is different from omnidirectional stimulation. The tests will be performed using a dedicated DBS lead connected to external neurostimulator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Subject is indicated to undergo DBS for Parkinson's disease or Essential Tremor according to criteria of the Study site
- •For Parkinson Disease:
- •Person is between 18 and 75 years of age
- •Established diagnosis of idiopathic Parkinson's disease with progression of symptoms for a minimum of 2 years.
- •Person has a history of at least 30% improvement on the Unified Parkinson's Disease Rating Scale with therapy in L-dopa (levodopa)
- •Weak control of symptoms by dopaminergic therapy (off phenomenon, fluctuations on / off, dyskinesia on)
- •For Essential Tremor:
- •Person is between 18 and 80 years of age
- •Established diagnosis of Essential Tremor for a minimum of 2 years
- •Functional disability due to tremor was not adequately controlled by medication for at least 3 months prior to implant.
- •Person has given his/her written consent
排除标准
- •Person suffering from an active major psychiatric disorder
- •Mattis Dementia Rating Scale score <130 or otherwise not capable of discernment
- •Presence of major co-morbidity or medical condition that may affect participation to the study
- •Presence of an electrical or electromagnetic implant (e.g., cochlear implant, pacemaker)
- •Person with a previous surgery for the treatment of Parkinson's disease or Essential Tremor
- •Person with a previous brain ablation procedure
- •Person who suffers from epilepsy
- •Person who is pregnant: a pregnancy test will be performed in women of childbearing age
- •Person with coagulopathies
- •Abuse of drugs or alcohol
研究组 & 干预措施
Directional lead
干预措施: directSTN Acute lead connected to external neurostimulator (Device)
结局指标
主要结局
Measurement of the therapeutic window's boundaries when stimulating in specific angular directions, and comparison to those obtained when stimulating in all directions.
时间窗: up to one hour during surgery
A therapeutic window is defined as the difference between the electrical current threshold at which a desired therapeutic effect is obtained and the current threshold at which side effects appear.
次要结局
- Electrical functionality of the study device during the test phase(1 day)