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Clinical Trials/NCT05230095
NCT05230095
Completed
Not Applicable

Social Cognition Dysfunctions in Parkinson's Disease

Hospices Civils de Lyon1 site in 1 country24 target enrollmentApril 11, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Hospices Civils de Lyon
Enrollment
24
Locations
1
Primary Endpoint
Emotional resonance task score
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
April 11, 2022
End Date
January 23, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Emotional resonance task score

Time Frame: 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).

Secondary Outcomes

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

Study Sites (1)

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