Select Stim: Selective Stimulation of the Subthalamic Nucleus in Parkinson's Disease. "A Feasibility Study"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- patients burden
研究概览
简要总结
In the advanced stages of Parkinson Disease deep brain stimulation of the subthalamic nucleus (STN DBS) is the next therapeutic option. Despite the beneficial motor effects there are important negative side-effects of STN DBS. Our hypothesis is that changes in cognition and behavior during STN DBS are related to stimulation of the non-motor parts of the STN.
The primary objective is to avoid cognitive and affective side effects by selective stimulation of the STN motor part.
The main objective of this feasibility study is to measure the patients burden and to test the technical feasibility.
Intervention:
The intervention is an expansion of the classical STN DBS procedure. The targeting using the multichannel registration system by stimulation of the motor cortex and registration of the subthalamic nucleus will be added to the procedure. For this procedure, it is necessary to place a subdural strip under the skull.
详细描述
Parkinson disease (PD) is a common neurodegenerative disorder, characterized by motor symptoms. Patients are initially treated successfully with drugs (e.g. levodopa), unfortunately use is limited due to severe side effects. In the advanced stages of PD neurosurgical treatment is the next therapeutic option.
As a result of dopamine depletion in PD the subthalamic nucleus (STN) displays a characteristic burst activity. This burst activity results in dysregulation of the electrical activity of the cortico-basal ganglia-thalamo-cortical circuitry and is expressed by Parkinsonian symptoms. That is why the STN is a main target for deep brain stimulation (DBS) in PD. Long-term follow-up (since 1993) shows long lasting beneficial effects on the motor function of PD patients.
Despite the beneficial motor effects there are important negative side-effects of STN DBS. These include both cognitive and affective changes during stimulation, 40% has one of these side effects. 10% experience difficulties during their daily functioning due to altered cognition or personality changes. Presently, the underlying mechanism of these stimulation induced behavioral changes is not fully understood and therefore adequate treatment is lacking.
The STN can be divided in three functionally and anatomically segregated parts: a motor part, a cognitive part and a limbic part. Our hypothesis is that changes in cognition and behavior during STN DBS are related to stimulation of the non-motor parts of the STN.
Currently, good candidates are excluded from STN DBS because of the high risk of behavioral disorders.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 40-75 years old
- •clinical findings consistent with idiopathic PD
- •suffer from severe response fluctuations and/or dyskinesias,
- •despite optimal drug treatment
- •initially a good response on levodopa.
排除标准
- •psychiatric co-morbidities and cognitive decline, e.g. dementia and psychosis, are excluded from this study.
- •The mini mental state exam (MMSE) score is not allowed to be <
- •significant cerebral atrophy,
- •causative factors of PD,
- •multiple white matter lesions or
- •focal brain anomalies
- •Hoehn and Yahr stage of 5 at the best moment of the day.
- •general contra-indications for surgery are considered as exclusion criteria, e.g. coagulopathies.
结局指标
主要结局
patients burden
时间窗: baseline
technical feasibility
时间窗: baseline
次要结局
- Cognition, and in particular impulsivity and affect.(baseline)
- Advantage of fMRI above TMS or double contrast MRI in the planning of the OR.(baseline)