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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT06225869
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Parkinson's disease (PD) based on United Kingdom Parkinson's Disease Society Brain Bank Criteria
* Patients in the PD phase called "motor and non-motor fluctuations stage".
* Presence of motor and non-motor fluctuations are based on:
1. For motor fluctuations: a score of 1 on item 4.1 and/or 1 on item 4.3 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale IV
2. For non-motor fluctuations: a score of 2 on item III of the Behavioral Assessment of Parkinson's Disease
* To be on dopaminergic replacement therapy.
Healthy controls:
subjects without any known central nervous system (CNS) lesion or CNS clinical signs on examination
Exclusion Criteria:
* Age greater than 80 years
* Dementia or mild cognitive impairment based on a score \<26 on the MOCA
* Ongoing depression with suicidal ideation
* Any clinically meaningful non-stable renal, hepatic, cardiovascular, respiratory cerebrovascular disease or other serious progressive physical diseases
* Participating in a pharmacological study
* Any MRI contraindications
* Intolerable "OFF" states when the effects of the PD medication wear off (e.g., severe pain, anxiety, depression at the end of the dose or in the morning upon waking)
* Inability to provide informed consent (legal guardianship)
* Inability to speak or read French.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06225869
Study Brief:
Protocol Section:
NCT06225869