Opioidergic and Noradrenergic Systems in Central Parkisonian Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2025-10-01

Brief Summary

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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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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type 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

Intervention Type 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)

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

Group Type EXPERIMENTAL

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

Intervention Type 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

Intervention Type 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 %.

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

Group Type EXPERIMENTAL

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

Intervention Type 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 %.

Interventions

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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 %.

Intervention Type OTHER

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 %.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes