BridgeMD
New treatment option for Parkinson Disease
Official title Pain in Parkinson's Disease: Exploration of the Serotonin System in Positron Emission Tomography (PET [18F]-MPPF)
ClinicalTrials.gov ID: NCT06008704
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, Haute-Garonne, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toulouse, Haute-Garonne, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.