Search / Trial NCT06225869

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

Launched by UNIVERSITY HOSPITAL, GENEVA · Jan 16, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how feelings of shame and embarrassment are experienced by people with Parkinson's disease and how dopamine replacement therapy (a common treatment for this condition) affects these feelings. Researchers want to understand the brain areas involved when patients feel shame, both when they are on their medication and when the medication has worn off. By using special brain scans, they will see how dopamine therapy changes the way the brain processes these emotions, which can impact the overall quality of life for patients.

To participate, individuals must be diagnosed with Parkinson's disease, be experiencing certain motor and non-motor fluctuations in their condition, and be receiving dopamine replacement therapy. Participants will include both those with Parkinson's and healthy individuals who do not have any central nervous system issues. If you join the study, you can expect to take part in tasks that may induce feelings of shame while being monitored in a scanner. It's important to note that participants must be able to provide informed consent and must be comfortable speaking and reading in French. This research could help improve our understanding of emotional challenges faced by people with Parkinson's disease and the role of medication in managing those challenges.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Diagnosis of Parkinson's disease (PD) based on United Kingdom Parkinson's Disease Society 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 the Movement Disorder Society Unified Parkinson's Disease Rating Scale IV
  • 2. For non-motor fluctuations: a score of 2 on item III of the Behavioral Assessment of Parkinson's Disease
  • To be on dopaminergic replacement therapy.
  • Healthy controls:
  • subjects without any known central nervous system (CNS) lesion or CNS clinical signs on examination
  • 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, respiratory cerebrovascular 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., severe pain, 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.

Trial Officials

Vanessa Fleury, MD

Principal Investigator

University Hospital, Geneva

About University Hospital, Geneva

The University Hospital of Geneva is a leading academic medical center committed to advancing healthcare through innovative research and clinical excellence. Renowned for its multidisciplinary approach, the hospital integrates cutting-edge medical research with high-quality patient care, fostering a collaborative environment that encourages the translation of scientific discoveries into practical treatments. As a prominent sponsor of clinical trials, the University Hospital of Geneva is dedicated to exploring new therapies and improving patient outcomes, while adhering to the highest ethical standards and regulatory compliance. Its robust infrastructure and expert clinical teams ensure the efficient execution of trials across various medical specialties, contributing significantly to the advancement of global health initiatives.

Locations

Geneva, , Switzerland

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0