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临床试验/NCT04933513
NCT04933513已完成不适用

Development and Validation of a French Scale Measuring Preoperative Expectations of Parkinson's Disease Patients Candidate to Deep Brain Stimulation : the DBS-PS (Deep Brain Stimulation Perception Scale)

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Validation of the Deep-brain stimulation - perception scale (DBS-PS scale)

研究概览

简要总结

Subthalamic nucleus deep brain stimulation (STN-DBS) has become a choice treatment for fluctuating Parkinson's disease (PD) patients, inducing remarkable improvement in motor symptoms. However, as PD is a complex neuropsychiatric disease, it has been hypothesized that in some patients, non-motor features, i.e. dysfunctional expectations for the result of neurosurgery, could interfere with postoperative result of DBS, even in case of motor improvement. Recent literature highlights the necessity to take these preoperative expectations into account, but to our knowledge, no specific scale investigating these cognitions in this PD-specific condition is available. So, the investigators developped the DBS-PS, a self-scale constructed to measure preoperative expectations for DBS, with 11 questions and visuo-analogical responses (1 to 10), theorically divided in three domains investigating the expectations concerning symptoms of PD, postoperative social-life and leisures, and postoperative familial and marital sphere. The investigators would like to validate this new-developped scale in the preoperative subthalamic nucleus deep brain stimulation population through patients recruited in the Predistim study, whereas the investigators did not recruite sufficiently patients through the PsyParkinson study, the one in which the DBS-PS scale was developed. The DBS-PS constitutes an interesting basis for the consideration of these cognitive and affective factors in preoperative PD patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Parkinson's disease patients included in the Predistim study and having completed the DBS-PS scale during the preoperative phase

排除标准

  • •Parkinson's disease patients not included in the Predistim study or not having completed the DBS-PS scale during the preoperative phase

结局指标

主要结局

Validation of the Deep-brain stimulation - perception scale (DBS-PS scale)

时间窗: during the inclusion/baseline period of Predistim study

Deep Brain Stimulation-Perception Scale completed by Parkinson's disease patients enrolled in the Predistim study; minimum scale score 0 - maximum scale score 50, for each sub-scores (3 dimensions) ; a higher score corresponding to higher expectations in the dimension, and a lower score coresponding to lower expectations in the dimension

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mme Mylène MEYER

psychologist, PhD

Central Hospital, Nancy, France

研究点 (1)

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