跳至主要内容
临床试验/NCT05230095
NCT05230095已完成不适用

Social Cognition Dysfunctions in Parkinson's Disease

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Emotional resonance task score

研究概览

简要总结

Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs with a major impact on the quality of life. Social cognition is a complex system relying on emotion recognition (neurons mirror system (NMS)), the theory of mind (with its two parts: emotional and cognitive), but also on the social and cultural environment and the personal history. The first step in this model is represented by the NMS, which seems to be altered in PD patients for both positive and negative emotions as shown in our preliminary study. The investigator purpose is to investigate the role of the treatment (levodopa and deep brain stimulation) on the functioning of the NMS

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For all participants:
  • Man or woman
  • Participant not objecting to participation in the study
  • Age ≥ 30 and ≤ 70 years old
  • Specific inclusion criteria for patients:
  • Patients with Parkinson's disease with motor fluctuations and dyskinesias receiving deep-brain stimulation
  • Patients able to understand the issues of the study

排除标准

  • For all participants:
  • Person deprived of liberty by judicial or administrative decision
  • Person subject to a legal protection measure (tutorship, curatorship)
  • Person concurrently participating in another research project who may interfere with the results or conclusions of this study
  • Specific exclusion criteria for healthy volunteers
  • Person presenting or having presented a neurological or psychiatric pathology
  • Person with a serious medical condition
  • Person who has exceeded the annual amount of compensation authorized for participation in research protocols

结局指标

主要结局

Emotional resonance task score

时间窗: 12 months following the inclusion

In the emotional resonance task, patients are asked to rate the emotional valence of fifteen 3-second silent videos. These movies show emotionally connoted motor interactions between two persons, each of them being depicted by 20 white dots moving on a black background (Point Light Displays (PLD) technique). Among these 15 videos, 5 has a negative valence (making someone cry, sadness, argument, hitting someone and anger), 5 has a positive valence (joy, dancing, giving a flower, laughing and cuddling) and 5 neutral valences (sit, stand, say hello, raise your arms and saw). The Emotional resonance score in parkinsonian patients undergoing treatment (dopaminergic or deep brain stimulation) will be compared to their score without treatment (OFF Dopa or OFF stimulation).

次要结局

  • Correlations between the emotional resonance task score and patients' quality of life self-questionnaire score (PDQ39)(12 months following the inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验