Social Cognition Dysfunctions in Parkinson's Disease

Parkinson Disease Clinical Trial

— cognition 2  

Official title:

Social Cognition Dysfunctions in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05230095
• Other study ID #: 69HCL21_1154
• Secondary ID: 2022-A00216-37
• Status: Completed
• Start date: April 11, 2022
• Est. completion date: January 23, 2024

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 23, 2024
• Est. primary completion date: January 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• Quality of life self-questionnaire
Quality of life will be assessed using a self-administered questionnaire in the patients group only.

Locations

Country	Name	City	State
France	Neurology C department, P. Wertheimer Hospital	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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