Social Cognition Dysfunctions in Parkinson's Disease (cognition 2)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bron, France, 69677
- Neurology C department, P. Wertheimer Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Parkinson's disease patients
30 parkinsonian patients scheduled for deep brain stimulation implantation surgery will be recruited
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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 will be assessed using a self-administered questionnaire in the patients group only.
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Controls
15 healthy volunteers matched in age and sex will be recruited
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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 |
|---|---|---|
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Emotional resonance task score
Time Frame: 12 months following the inclusion
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlations between the emotional resonance task score and patients' quality of life self-questionnaire score (PDQ39)
Time Frame: 12 months following the inclusion
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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.
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12 months following the inclusion
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
Studies a U.S. FDA-regulated device product
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