NCT07127146Not yet recruiting
Opioidergic and Noradrenergic Systems in Central Parkisonian Pain
Role of Opioidergic and Noradrenergic Systems in Central Parkisonian Pain
Source: ClinicalTrials.gov · Last updated 17 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- First submitted
- 18 Jun 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 1 Oct 2025
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Parkinson disease
- NCT number
- NCT07127146
What you commit to
- Study type: Interventional
- Planned participants: 55
- From 1 Oct 2025 to the primary completion date, 1 Oct 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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).
- Having used recreational drugs interfering with the opioid and noradrenergic systems (cannabis, CBD, opiates, MDMA, ecstasy) in the last 3 months or chronic use
Other illness
- Having atypical Parkinson's disease (Group 1 and 2)
- Parkinson's disease with disabling dyskinesia and/or severe tremor (Group 1 and 2)
- History of head trauma with loss of consciousness lasting more than 30 minutes
- Under psychiatric care
Other
- 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)
- 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 any treatment
- Presenting or having presented a dependence on any addictive substance according to DSM-IV-TR criteria, with the exception of tobacco.
- Pregnant women, women in labor or nursing mothers
- Persons deprived of their liberty by judicial or administrative decision
- 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
Who the study is looking for
- 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)
Age in the registry: 30 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Neurologique Pierre Wertheimer Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| CHU de Clermont-Ferrand Hôpital Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| CHU de Toulouse - Hôpital Purpan Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.