Exploring the serotonin system's role in pain for Parkinson's patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project investigates how the serotonin system contributes to central pain in patients with Parkinson's Disease (PD). It will involve brain imaging techniques, including positron emission tomography (PET) to visualize serotonin receptors and MRI to assess brain structure and function. The study will compare PD patients experiencing central pain with those who do not, aiming to understand the underlying mechanisms of pain in this population. By examining the nociceptive integration process and the role of serotonin, the research seeks to provide insights into pain management for PD patients.

Why it matters

Who can join: the full rules

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's running

• Centre Hospitalier Universitaire de Toulouse
  Toulouse, Haute-Garonne, France Recruiting

Study contacts

• Principal investigator: Christine BREFEL-COURBON, MD PhD — University Hospital, Toulouse
• Study coordinator: Christine BREFEL-COURBON, MD PhD
• Email: Brefel-Courbon Christine <christine.brefel-courbon@univ-tlse3.fr>
• Phone: 33-561777753

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.