Social Cognition Dysfunctions in Parkinson's Disease (cognition 2)

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: social cognition tests; Behavioral: Quality of life self-questionnaire

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Neurology C department, P. Wertheimer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients likely to participate in the study and verifying the eligibility criteria will be identified within the Neurology C department as part of their neurological follow-up before and after deep brain stimulation.

Healthy volunteers will be recruited among the spouses of the patients or via association like France Parkinson.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parkinson's disease patients; 30 parkinsonian patients scheduled for deep brain stimulation implantation surgery will be recruited	Behavioral: social cognition tests; The evaluation of social cognition will be carried out using questionnaires and a point lights computer test. During the computer test, participants have to watch several short sequences of interactions between two silhouettes and give an interpretation of the scene. Patients will be evaluated twice: one time before the surgery and a second time 1 year after surgery. Healthy volunteers will be evaluated only one time.; Behavioral: Quality of life self-questionnaire; Quality of life will be assessed using a self-administered questionnaire in the patients group only.
Controls; 15 healthy volunteers matched in age and sex will be recruited	Behavioral: social cognition tests; The evaluation of social cognition will be carried out using questionnaires and a point lights computer test. During the computer test, participants have to watch several short sequences of interactions between two silhouettes and give an interpretation of the scene. Patients will be evaluated twice: one time before the surgery and a second time 1 year after surgery. Healthy volunteers will be evaluated only one time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional resonance task score	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).	12 months following the inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlations between the emotional resonance task score and patients' quality of life self-questionnaire score (PDQ39)	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.	12 months following the inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Actual): January 23, 2024
• Study Completion (Actual): January 23, 2024

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Parkinson Disease; Deep Brain Stimulation; emotional recognition
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 69HCL21_1154; 2022-A00216-37 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No