Pain in Parkinson's Disease: Exploration of the Serotonin System in Positron Emission Tomography (PET [18F]-MPPF)
Recruiting · NCT06008704 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Toulouse
View the official record on ClinicalTrials.gov →Interventions studied
Clinical assessmentMRIPain characteristics assessmentThermotestUPDRS-III Scale[18F]-MPPF PET scan
What this trial is about
This project will explore the involvement of the serotonin system in the pathophysiology of PD-related central pain. Thus, the serotonin system will be evaluated in PD patients with and without central pain who will benefit from brain positron emission tomography (PET) allowing in vivo imaging of 5HT1A receptors and multimodal brain MRI including morphometric imaging and functional connectivity (resting state acquisition).
Who can take part
Age range
40 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients with PD defined according to United Kingdom Parkinson's Disease Brain Bank (UKPDSBB) criteria
- Patients with stable anti-parkinsonian treatment for at least 4 weeks prior to inclusion
- Patients with a Montreal Cognitive Assessment (MoCA) score \> 25
- Patients with a Hospital Anxiety and Depression Scale (HADS)-D score ≥ 11
- Person affiliated or benefiting from a social security scheme.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
- For patients with pain
- Patients with PD-related central pain defined according to the criteria of Marques et al, 2019
- Patients with chronic central pain (i.e. present for at least 3 months)
- Patients who have average pain over the previous month according to a VAS ≥ 4.
- For patients without pain
- Patients who do not have pain defined as VAS ≤ 4, meaning that it does not interfere with daily activity.
Exclusion criteria
- Patients treated with second line therapy
- Patients with a history of significant psychiatric pathology according to the investigator
- Patients treated with drugs interacting with 5HT1A receptors in the previous 4 weeks
- Patients with contraindication to MRI
- Patients refusing to be informed of an abnormality discovered during brain imaging
- Patients with dyskinesias judged by the investigator to be disabling for imaging.
- Patients under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision
- Pregnant woman, breastfeeding woman
Where it is running
1 location listed.
- Centre Hospitalier Universitaire de Toulouse - Toulouse, Haute-Garonne, France