2022-501123-24-00招募中2 期
Pathophysiology of pain in Parkinson's disease: exploration of the serotonin system in positron emission tomography (PET [18F]-MPPF) - PD PAIN
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- The primary endpoint is the distribution volume ratio of [18F]-MPPF (DVR) using the cerebellum as the reference region, measured in both groups of painful and non-painful PD patients
研究概览
简要总结
The primary endpoint is the distribution volume ratio of [18F]-MPPF (DVR) using the cerebellum as the reference region, measured in both groups of painful and non-painful PD patients
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with Parkinson's disease defined according to UKPDSBB criteria
- •Men and women aged between 35 and 85 years
- •Patients with stable anti-parkinsonian treatment for at least 2 weeks prior to V2
- •Patients with a MOCA score ≥ 24
- •Patients with a HADS-D score ≤ 11
- •Person affiliated or benefiting from a social security scheme.
- •Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
排除标准
- •Patients treated with second line therapy (deep brain stimulation, pump - duodopa and apokinon)
- •Patients with a history of significant psychiatric pathology according to the investigator
- •Patients treated with drugs interacting with 5HT1A receptors in the previous 2 weeks ( serotonergic antidepressants)
- •Patients with contraindication to MRI
- •Patients refusing to be informed of an abnormality discovered during brain imaging
- •Patients with dyskinesias judged by the investigator to be disabling for imaging
- •Patients under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision
- •Pregnant woman, breastfeeding woman
- • Triptans taken in the 48 hours preceding PET
结局指标
主要结局
The primary endpoint is the distribution volume ratio of [18F]-MPPF (DVR) using the cerebellum as the reference region, measured in both groups of painful and non-painful PD patients
The primary endpoint is the distribution volume ratio of [18F]-MPPF (DVR) using the cerebellum as the reference region, measured in both groups of painful and non-painful PD patients
次要结局
- assess the relationship between [18F]-MPPF uptake and : central pain intensity, other central pain characteristics and pain-induced functional discomfort only in painful parkinsonian patients pain perception thresholds in the 2 groups of patients
- compare the functional networks related to pain on resting-state functional MRI between the 2 groups of patients;
- evaluate, for the 2 groups of patients, the link between : cerebral structural characteristics (cerebral macro/microstructural markers collected in MRI) and pain parameters (central pain intensity, and other pain characteristics, pain-induced functional discomfort and pain perception thresholds); [18F]-MPPF uptake and pain-related functional networks in resting-state MRI
研究者
clinical research assistant (sponsor)
Scientific
Centre Hospitalier Universitaire De Toulouse
研究点 (1)
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