Status:
RECRUITING
Pain in Parkinson's Disease: Exploration of the Serotonin System in Positron Emission Tomography (PET [18F]-MPPF)
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
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 centra...
Detailed Description
The prevalence of chronic pain in PD can be estimated at 60-80% from several epidemiological studies. Both semiological and pathophysiological classification proposes specific and non-specific pain in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06008704
Start Date
January 1 2024
End Date
September 1 2026
Last Update
May 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier Universitaire de Toulouse
Toulouse, Haute-Garonne, France, 31000