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OpenTrials
Completed

NCT Number: NCT05230095

Social Cognition Dysfunctions in Parkinson's Disease

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

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Neurology C department, P. Wertheimer Hospital

Bron, 69677, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

social cognition tests

Behavioral

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

Behavioral

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

Primary outcomes

  1. 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

  1. Correlations between the emotional resonance task score and patients' quality of life self-questionnaire score (PDQ39)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: cognition 2

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2022
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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