Opioidergic and Noradrenergic Systems in Central Parkisonian Pain

NCT07127146 | Not Yet Recruiting

• 1 other identifier: 69HCL24_0721
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Parkinson Disease

Keywords

Pain; Parkinson's disease; Noradrenergic system; Opioidergic system; PET-MRI

Outcome Measures

Primary Outcomes (1)

• Difference between non-displaceable binding potential of radiotracer in brain region involved in pain

  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

  At the time of PET-MRI scan at Day 75

Secondary Outcomes (3)

• Correlation between BPND of both tracer and pain intensity of parkinsonian patient

  At the time of PET-MRI scan at Day 75

• Pain matrix area

  At the time of PET-MRI scan at Day 75

• ASL measure

  At the time of PET-MRI scan at Day 75

Study Arms (3)

PD-P (Parkinson's patient with pain)

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Healthy volunteers

EXPERIMENTAL

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

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

Interventions

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

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 %.

Healthy volunteers; PD-NP (Parkinson's patient with no pain); PD-P (Parkinson's patient with pain)

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

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 %.

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

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Hôpital Neurologique Pierre Wertheimer

Bron, 69677, France

Location

CHU de Clermont-Ferrand Hôpital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

CHU de Toulouse - Hôpital Purpan

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Parkinson Disease; Pain

Interventions

carfentanil

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stéphane THOBOIS, PHD

  Hospices Civils de Lyon

  STUDY DIRECTOR

Central Study Contacts

Mathilde Millot-Troesch, CRA

CONTACT

04 72 35 70 58; mathilde.millot-troesch@chu-lyon.fr

Elise Météreau, CRA

CONTACT

04 27 85 62 08; elise.metereau@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned in 3 parallel groups without randomization : * group1 20 patients analyzable with Parkinson's disease suffering from central pain (PD-P) * Group 2 20 patients analyzable with Parkinson's disease without central pain (PD-NP) matched for sex and age. * Group 3 15 healthy volunteers analyzable (HC) matched for sex and age.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: August 17, 2025
• Study Start: October 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-06

Locations

FR (3)