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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT04261569
Eligibility Criteria:
Inclusion Criteria:
1. Clinically diagnosed idiopathic Parkinson's disease according to MDS criteria developed by R.B. Postuma (Anang et al, Neurology, 2014)
2. Dopaminergic denervation confirmed in PET \[11C\]PE2I with a decrease in tracer fixation at the striatum level of at least 30% on average compared to the white matter fixation of the cerebellum
3. Patients willing to start dopaminergic treatment
4. Very early stage of the disease:
1. Diagnosis of recent Parkinson's disease (less than two years after a neurologist's diagnosis)
2. Hoehn and Yahr Stage 1 to 2
3. Maximum 2 tremor on the MDS-UPDRS scale
4. Naive of any anti-Parkinsonian treatment
5. Between 25 and 65 years of age
6. Score on Beck Depression Inventory (BDI) scale below the value of 20
7. Easy handling of the French language in oral and written language
8. Social security affiliates or beneficiaries of such a scheme
9. Informed and written consent signed by the patient
Exclusion Criteria:
1. All categories of protected persons: pregnant woman, parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, person subject to a measure of legal protection, hospitalized for psychiatric disorder
2. Carcinological history in the previous 5 years, not stabilized
3. Uncontrolled medical condition that may lead to complications
4. Preoperative brain Magnetic Resonance Imaging (MRI) showing brain damage that may be responsible for Parkinson's syndrome or a significant surgical risk (e.g. vascular malformation)
5. Surgical or anesthetic contraindication
6. History of brain infection with herpes virus
7. Contraindication to MRI (claustrophobia, non-compatible mri metal prosthesis, etc.)
8. Predictable need for frequent use of MRI scans after surgery
9. Unstabilized psychotropic treatment
10. Patient with cognitive impairment at the outset of illness (Montreal Cognitive Assessment (MoCA) score - 26)
11. Atypias suspecting atypical Parkinson's syndrome
12. Chronic treatment with L-Dopa or dopamine agonist
13. Presence of another serious pathology (major depressive episode, suicidal patient, active psychosis ...)
14. Participation in another interventional clinical trial
15. Wearing pace makers other than brain
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT04261569
Study Brief:
Protocol Section:
NCT04261569