Opioidergic and Noradrenergic Systems in Central Parkisonian Pain (PAINPARK)

Civil Hospices of Lyon

Status: Not yet enrolling

Conditions: Parkinson Disease

Treatments: Other: PET-MRI exam with administration of [11C]Carfentanil; Other: PET-MRI exam with administration of [11C]Yohimbine

Study type: Interventional

Funder types: Other

Identifiers

NCT07127146

69HCL24_0721

Details and patient eligibility

About

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).

Enrollment: 55 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 3 patient groups

PD-P (Parkinson's patient with pain)

Experimental group

Description:

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

Treatment:

Other: PET-MRI exam with administration of [11C]Yohimbine

Other: PET-MRI exam with administration of [11C]Carfentanil

PD-NP (Parkinson's patient with no pain)

Experimental group

Description:

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

Treatment:

Other: PET-MRI exam with administration of [11C]Yohimbine

Other: PET-MRI exam with administration of [11C]Carfentanil

Healthy volunteers

Experimental group

Description:

Healthy volunteers without chronic pain and with a VAS score below 3 points They will perform a PET MRI with the \[11C\]Carfentanil radiotracer

Treatment:

Other: PET-MRI exam with administration of [11C]Carfentanil