Exploring the Effect of Electrode Implantation for DBS on Brain Function During Rest and During Semantic Verbal Fluency Task Using SPECT With Tc-ECD
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- CBF values in different brain regions
研究概览
简要总结
The goal of this study is to explore the effect of subthalamic nucleus (STN)-DBS surgery and stimulation in PD (Parkinson's disease) patients on regional cerebral blood (CBF) flow during cognitive task performance or at rest.
详细描述
In this study subjects undergo SPECT scans for CBF mapping. PD patients before the surgery and healthy controls undergo two scans. PD patients after the surgery undergo four scans. PD patients who undergo two scans before the surgery, undergo only two scans after the surgery.
Uptake of Tc-ECD, a CBF radiotracer, is done in the following conditions:
- For PD patients before the surgery - during the performance of the semantic verbal fluency task or at rest (total of 2 scans).
- For PD patients after the surgery- during the performance of the semantic verbal fluency task or at rest, either at on-stimulation or off-stimulation condition (total of 4 scans). The stimulator is turned off by the neurologist for 10 min.
- PD patients before and after the surgery- during performance of the semantic verbal fluency task or at rest before the surgery and during performance of the semantic verbal fluency task or at rest after the surgery only at off-stimulation condition (Total of 4 scans).
- Healthy controls - during the performance of the semantic verbal fluency task or at rest (total of 2 scans).
Following the Tc-ECD injection, the subjects are scanned by Irix SPECT camera for 15min.
Scans are analyzed and the regional CBF is measured using imaging software. Statistical analysis is done to discover the effect of the surgery, stimulation and the disease on blood flow at rest and during task performance. In addition, differences between groups in number of words produced during the task are also statistically analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Progressive idiopathic PD
- •For control group - age-matched to study groups
排除标准
- •Progressive dementia or other psychiatric disorders
- •Other neurological conditions
- •Other physical disease
- •Intolerance of "off stimulation" state
- •Involuntary head motions
- •Hearing deficits
研究组 & 干预措施
PD, DBS, healthy controls
Patients with idiopathic PD before or after DBS surgery (during on or off-stimulation) and healthy controls.
干预措施: Injection of 15mCi of Tc-ECD and scanning by SPECT camera (Radiation)
PD, DBS, healthy controls
Patients with idiopathic PD before or after DBS surgery (during on or off-stimulation) and healthy controls.
干预措施: Semantic verbal fluency task performance (Behavioral)
PD, DBS, healthy controls
Patients with idiopathic PD before or after DBS surgery (during on or off-stimulation) and healthy controls.
干预措施: Turning off the stimulator (Device)
结局指标
主要结局
CBF values in different brain regions
时间窗: 3 months to 2 years post-surgery
次要结局
- Number of words produced in the semantic fluency task(3 months to 2 years post-surgery)