Opioidergic and Noradrenergic Systems in Central Parkisonian Pain

Официальное название

Role of Opioidergic and Noradrenergic Systems in Central Parkisonian Pain

Обзор

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).

Вмешательства

• Другое PET-MRI exam with administration of [11C]Carfentanil
  Recording of functional neuroimaging data will begin immediately after intravenous injection of \[11C\]Carfentanil and will last for 51 minutes in a resting state. The dose will be 250 MBq/kg +-10 %.
• Другое PET-MRI exam with administration of [11C]Yohimbine
  Recording of functional neuroimaging data will begin immediately after intravenous injection of \[11C\]Yohimbine and will last for 70 minutes in a resting state. The dose will be 370 MBq/kg +- 10 %.

Первичные конечные точки

• Difference between non-displaceable binding potential of radiotracer in brain region involved in pain [Срок оценки: At the time of PET-MRI scan at Day 75]

Вторичные конечные точки (3)

• Correlation between BPND of both tracer and pain intensity of parkinsonian patient [Срок оценки: At the time of PET-MRI scan at Day 75]
• Pain matrix area [Срок оценки: At the time of PET-MRI scan at Day 75]
• ASL measure [Срок оценки: At the time of PET-MRI scan at Day 75]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 3 центра

• Hôpital Neurologique Pierre Wertheimer — Bron
• CHU de Clermont-Ferrand Hôpital Gabriel Montpied — Clermont-Ferrand
• CHU de Toulouse - Hôpital Purpan — Toulouse

Идентификаторы

NCT: NCT07127146 · 69HCL24_0721

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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