Effect of Dopamine on Specific Processing of Shame and Embarrassment in Parkinson's Disease

Last updated: March 2, 2024
Sponsor: University Hospital, Geneva
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Assessments in ON and OFF levodopa state

Clinical Study ID

NCT06225869
2022-00760
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Shame and embarrassment are two self-conscious emotions frequently experienced by Parkinson's disease (PD) patients. Shame and embarrassment scores strongly correlate with patient's quality of life, anxiety and depression ratings. However, the neurobiology of shame and embarrassment in PD and the influence of dopaminergic replacement therapy (DRT) is poorly understood.

The aim of this study is to characterize how brain structures and neuronal networks involved in Parkinson's disease-related shame, non-Parkinson's disease related shame and neutral control scenarios, are modulated by dopaminergic replacement therapy. For this purpose, functional MRI and connectivity measures between the basal ganglia and shame-related network will be analyzed while PD patients will perform a shame-induction task during both ON- (i.e. during the effect of DRT) and OFF-DRT (i.e. during the withdrawal of DRT) conditions. Correlation with clinical measures will be made.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Parkinson's disease (PD) based on United Kingdom Parkinson's DiseaseSociety Brain Bank Criteria
  • Patients in the PD phase called "motor and non-motor fluctuations stage".
  • Presence of motor and non-motor fluctuations are based on:
  1. For motor fluctuations: a score of 1 on item 4.1 and/or 1 on item 4.3 of theMovement Disorder Society Unified Parkinson's Disease Rating Scale IV
  2. For non-motor fluctuations: a score of 2 on item III of the Behavioral Assessmentof Parkinson's Disease
  • To be on dopaminergic replacement therapy. Healthy controls: subjects without any known central nervous system (CNS) lesion or CNS clinical signs onexamination

Exclusion

Exclusion Criteria:

  • Age greater than 80 years
  • Dementia or mild cognitive impairment based on a score <26 on the MOCA
  • Ongoing depression with suicidal ideation
  • Any clinically meaningful non-stable renal, hepatic, cardiovascular, respiratorycerebrovascular disease or other serious progressive physical diseases
  • Participating in a pharmacological study
  • Any MRI contraindications
  • Intolerable "OFF" states when the effects of the PD medication wear off (e.g., severepain, anxiety, depression at the end of the dose or in the morning upon waking)
  • Inability to provide informed consent (legal guardianship)
  • Inability to speak or read French.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Assessments in ON and OFF levodopa state
Phase:
Study Start date:
April 19, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • University Hospital, Geneva

    Geneva, 1204
    Switzerland

    Active - Recruiting

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