Role of Opioidergic and Noradrenergic Systems in Central Parkisonian Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- Difference between non-displaceable binding potential of radiotracer in brain region involved in pain
研究概览
简要总结
The goal of this study is to evaluate the differences in functional physiopathology of the opioid and noradrenergic systems between Parkinson's patients with central pain and Parkinson's patients without central pain. Using PET-MRI data, investigators aim to observe opioids receptors availability using [11C]Carfentanil (µ opioid receptor agonist) and altered α2-AR density with [11C]Yohimbine (adrenergic α2 receptor antagonist).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of Parkinson's disease based on MDS-UPDRS criteria (Group 1 and 2)
- •Dopaminergic therapy stable with stable dose for at least 4 weeks prior to J0
- •Affiliate to a social security or similar system
- •Having given written consent to participate in the study, free and informed.
- •Having chronic pain more than 3 month (Group 1)
- •Without chronic pain (Groupe 2 and 3)
- •Having central pain using specific algorithm (Marques et al., 2019)
- •Having pain intensity at least 4 on VAS (Visual Analogue Scale) during the last month (Group 1)
- •Having pain intensity lower than 3 on VAS (Visual Analogue Scale) during the last month (Group 2 and 3)
排除标准
- •Having atypical Parkinson's disease (Group 1 and 2)
- •Parkinson's disease with disabling dyskinesia and/or severe tremor (Group 1 and 2)
- •Any contraindications to having a brain MRI or PET scan (e.g., pacemaker, metal foreign body, claustrophobia, deep brain stimulation or apomorphin pump unable to be turn off)
- •History of head trauma with loss of consciousness lasting more than 30 minutes
- •Not agreeing to be informed in the event of incidental discovery of an abnormality on MRI or during neuropsychological assessment
- •Presence of cognitive dysfunction (defined as MoCA score < 24)
- •Severe depression (BDI > 29)
- •unable to stop the opioid treatment the week before the imaging exam ( e.g., Antarène codéine, Claradol codéine, Codoliprane, Dafalgan codéine, Euphon, Klipal, Lindilane, Néo-codion, Paderyl, Prontalgine, Pulmoserum, Tussipax ; Opium : Izalgi, Lamaline, Colchimax, Dropizal ; Morphine : Actiskenan, Moscontin, Oramorph, Sevredol, Skenan ; Buprénorphine : Bupensan, Buvidal, Orobupre, Sixmo, Suboxone, Subutex, Temgesic, Zubsolv ; Dihydrocodéine : Dicodin ; Hydromorphone : Sophidone ; Nalbuphine : Nalpain ; Fentanyl : Abstral, Actiq, Breakyl, Durogesic, Effentora, Instanyl, Matrifen, Pecfent, Recivit ; Méthadone : Methadone AP-HP, Zorvon ; Oxycodone : Oxsynia, Oxycontin, Oxynorm, Oxynormoro ; Tramadol : Biodalgic, Contramal, Ixprim, Monoalgic, Monocrixo, Orozamudol, Skudexum, Topalgic, Zaldiar, Zamudol, Zumalgic)
- •unable to stop any treatment
- •Treated with level 1 analgesics (NSAIDs, acetaminophen) or coanalgesics (antidepressants, antiepileptics) unless treatment has been stable for at least 4 weeks prior to the study and does not interfere with the noradrenergic system (list above).
- •Presenting or having presented a dependence on any addictive substance according to DSM-IV-TR criteria, with the exception of tobacco.
- •Having used recreational drugs interfering with the opioid and noradrenergic systems (cannabis, CBD, opiates, MDMA, ecstasy) in the last 3 months or chronic use
- •Pregnant women, women in labor or nursing mothers
- •Persons deprived of their liberty by judicial or administrative decision
- •Under psychiatric care
- •Admitted to a health or social institution for purposes other than research
- •Under legal protection (guardianship, curatorship)
- •Participant in another interventional study with an exclusion period still in progress at pre-inclusion
- •Having exceeded the annual amount of compensation authorized for participation in research protocols
研究组 & 干预措施
PD-P (Parkinson's patient with pain)
Parkinson's patients suffering from chronic and central pain and with a VAS score of at least 4 points.
They will perform 2 different PET MRI with radiotracer , one using [11C]Carfentanil and the other one using [11C]Yohimbine
干预措施: PET-MRI exam with administration of [11C]Carfentanil (Other)
PD-P (Parkinson's patient with pain)
Parkinson's patients suffering from chronic and central pain and with a VAS score of at least 4 points.
They will perform 2 different PET MRI with radiotracer , one using [11C]Carfentanil and the other one using [11C]Yohimbine
干预措施: PET-MRI exam with administration of [11C]Yohimbine (Other)
PD-NP (Parkinson's patient with no pain)
Parkinson's patients without chronic and central pain and with a VASscore below 3 points They will perform 2 different PET MRI with radiotracer , one using [11C]Carfentanil and the other one using [11C]Yohimbine
干预措施: PET-MRI exam with administration of [11C]Carfentanil (Other)
PD-NP (Parkinson's patient with no pain)
Parkinson's patients without chronic and central pain and with a VASscore below 3 points They will perform 2 different PET MRI with radiotracer , one using [11C]Carfentanil and the other one using [11C]Yohimbine
干预措施: PET-MRI exam with administration of [11C]Yohimbine (Other)
Healthy volunteers
Healthy volunteers without chronic pain and with a VAS score below 3 points They will perform a PET MRI with the [11C]Carfentanil radiotracer
干预措施: PET-MRI exam with administration of [11C]Carfentanil (Other)
结局指标
主要结局
Difference between non-displaceable binding potential of radiotracer in brain region involved in pain
时间窗: At the time of PET-MRI scan at Day 75
Differences between binding potential (BPND )of \[11C\]Carfentanil on the µ-opioid receptor and \[11C\]Yohimbine on α2-AR in PD-P and PD-NP patients
次要结局
- Correlation between BPND of both tracer and pain intensity of parkinsonian patient(At the time of PET-MRI scan at Day 75)
- ASL measure(At the time of PET-MRI scan at Day 75)
- Pain matrix area(At the time of PET-MRI scan at Day 75)