Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT06008704
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT06008704
Study Brief:
Protocol Section:
NCT06008704