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

NCT06225869 | Recruiting

• 1 other identifier: 2022-00760
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Difference in BOLD activity in ON versus OFF state

  Difference in brain Blood Oxygenation Level Dependent (BOLD) activity between ON-levodopa versus OFF-levodopa patients, as well as age-matched healthy controls during the imaginary ideation of PD-shame related scenarios, non-PD shame related scenarios as well as neutral scenarios.

  fMRI at rest and during a shame induction task, 1 hour in ON state and 1 hour in OFF state

Interventions

Assessments in ON and OFF levodopa state BEHAVIORAL

Neurological assessment, neuropsychological assessment, and fMRI in ON and OFF levodopa state

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PD patients will be recruited from the outpatient movement disorder clinic of the Neurology Department at the Geneva University Hospital (HUG). Patients, who participated in previous studies and who are now followed up by private physicians, could also be contacted by trained members of the clinic/research staff to propose the study. Flyers with a brief explanation of the project could also be distributed to the physicians to invite patients to consider participating and reach out to a staff member for further information. Healthy controls will be recruited among the patients' spouses and through advertisement placed in the HUG and the University Medical Centre.

You may qualify if:

• 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:
• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospital, Geneva

Geneva, 1204, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Vanessa Fleury, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Fleury, MD

CONTACT

+41223728337; Vanessa.FleuryNissen@hcuge.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 26, 2024
• Study Start: April 19, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)