Exploring how dopamine affects feelings of shame and embarrassment in Parkinson's disease

Impact of Dopamine Replacement Therapy on Shame and Embarrassment-specific Processing and Its Clinical Relevance in Parkinson's Disease Patients

This study is testing how dopamine affects feelings of shame and embarrassment in people with Parkinson's disease while they are on and off their medication.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University Hospital, Geneva (Academic / other)
• Locations: 1 site (Geneva)
• Trial ID: NCT06225869 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the neurobiology of shame and embarrassment in patients with Parkinson's disease (PD) and how these emotions are influenced by dopaminergic replacement therapy (DRT). Using functional MRI, the study will analyze brain structures and neuronal networks while patients perform tasks designed to induce shame under both ON (during DRT) and OFF (after withdrawal of DRT) conditions. The research will correlate these findings with clinical measures to better understand the emotional experiences of PD patients and the role of dopamine in modulating these feelings.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with Parkinson's disease who experience motor and non-motor fluctuations and are currently on dopaminergic replacement therapy.

Not a fit: Patients over 80 years old, those with dementia or significant cognitive impairment, or those with ongoing severe depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of emotional processing in Parkinson's disease, potentially leading to improved therapeutic strategies.

How similar studies have performed: While the specific focus on shame and embarrassment in PD is novel, related studies on emotional processing in neurological conditions have shown promising results.

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.

Where this trial is running

Geneva

• University Hospital, Geneva — Geneva, Switzerland (Recruiting)

Study contacts

• Principal investigator: Vanessa Fleury, MD — University Hospital, Geneva
• Study coordinator: Vanessa Fleury, MD

Conditions Parkinson Disease