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NCT Number: NCT07127146

Opioidergic and Noradrenergic Systems in Central Parkisonian Pain

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).

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Neurologique Pierre Wertheimer, Bron, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 %.

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 %.

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Correlation between BPND of both tracer and pain intensity of parkinsonian patient

    Time frame: At the time of PET-MRI scan at Day 75

    Correlation between BPND measured with the [11C]Carfentanil and the[11C]Yohimbine and the pain intensity of all PD patient measured with clinical scores

  2. Pain matrix area

    Time frame: At the time of PET-MRI scan at Day 75

    Compare the resting functional connectivity in the pain matrix area (insula, pre frontal cortex, thalamus) between groups of patients with and without pain.

  3. ASL measure

    Time frame: At the time of PET-MRI scan at Day 75

    Observation of the blood flow modification through ASL measure in the brain pain areas between PD-P and PD-NP patients

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Météreau, CRA

CONTACT

[email protected]

04 27 85 62 08

Mathilde Millot-Troesch, CRA

CONTACT

[email protected]

04 72 35 70 58

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Role of Opioidergic and Noradrenergic Systems in Central Parkisonian Pain

Acronym: PAINPARK

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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