Impact of Dopamine Replacement Therapy on Shame and Embarrassment-specific Processing and Its Clinical Relevance in Parkinson's Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Difference in BOLD activity in ON versus OFF state
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Difference in BOLD activity in ON versus OFF state
时间窗: fMRI at rest and during a shame induction task, 1 hour in ON state and 1 hour in 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.
次要结局
未报告次要终点
研究者
Vanessa Fleury
Principal Investigator
University Hospital, Geneva