Social Cognition Dysfunctions in Parkinson's Disease

Completed

• Conditions: Parkinson Disease
• Interventions: Behavioral: social cognition tests; Behavioral: Quality of life self-questionnaire

• Registration Number: NCT05230095
• Lead Sponsor: Hospices Civils de Lyon

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-08
• Study Start: 2022-04-11
• Primary Completion: 2024-01-23
• Study Completion: 2024-01-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson's disease patients	social cognition tests	30 parkinsonian patients scheduled for deep brain stimulation implantation surgery will be recruited
Parkinson's disease patients	Quality of life self-questionnaire	30 parkinsonian patients scheduled for deep brain stimulation implantation surgery will be recruited
Controls	social cognition tests	15 healthy volunteers matched in age and sex will be recruited

Primary Outcome Measures

Name	Time	Method
Emotional resonance task score	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 Outcome Measures

Name	Time	Method
Correlations between the emotional resonance task score and patients' quality of life self-questionnaire score (PDQ39)	12 months following the inclusion	PDQ39 (Parkinson's Disease Questionnaire) is a 39-item self-report questionnaire assessing Parkinsons' disease-specific health and well-being over the last month. PDQ39 provide a summary score of the impact of the illness on functioning and well-being.

Trial Locations

Locations (1)

Neurology C department, P. Wertheimer Hospital; 🇫🇷 Bron, France