NCT06008704 Pain in Parkinson's Disease: Exploration of the Serotonin System in Positron Emission Tomography (PET [18F]-MPPF)
| NCT ID | NCT06008704 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2024-01-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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).
Eligibility Criteria
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
Contact & Investigator
Christine BREFEL-COURBON, MD PhD
✉ Brefel-Courbon Christine <christine.brefel-courbon@univ-tlse3.fr>📞 33-561777753
Christine BREFEL-COURBON, MD PhD
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT06008704 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06008704 currently recruiting?
Yes, NCT06008704 is actively recruiting participants. Contact the research team at Brefel-Courbon Christine <christine.brefel-courbon@univ-tlse3.fr> for enrollment information.
Where is the NCT06008704 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT06008704 clinical trial?
NCT06008704 is sponsored by University Hospital, Toulouse. The principal investigator is Christine BREFEL-COURBON, MD PhD at University Hospital, Toulouse. The trial plans to enroll 34 participants.
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