Informations générales (source: ClinicalTrials.gov)
Clinical Trial for Near Infrared Endoventricular Illumination for Neuroprotection in Very Early Cases of Parkinson's Disease (Ev-NIRT) (Ev-NIRT)
Interventional
N/A
University Hospital, Grenoble (Voir sur ClinicalTrials)
décembre 2020
avril 2032
02 avril 2025
Parkinson's disease has only pharmacological (essentially dopaminergic) and surgical
treatment (essentially high-frequency deep brain stimulation), that are symptomatically
effective. none of them is curative, and has the ability to slow down the disease and to
protect dopaminergic neurons from death by neurodegeneration. Experimental results, based
on preclinical studies, suggest that brain illumination in the Near-InfraRed (NIR) range
is likely to slow down this neurodegenerative process.
Thus, a medical device system (called Ev-NIRT) has been developed for 670 nm
intracerebral illumination of the substantia nigra pars compacta (SNpc), and is planned
to be tested for the treatment of Parkinson's disease.
In this pilot study the investigators will evaluate the feasibility and tolerance of
surgery and brain illumination thanks to the Ev-NIRT medical device, in a group of 7 de
novo Parkinson's patients implanted with the innovative medical device. Patients will be
monitored for 4 years.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLINATEC - 38000 - Grenoble - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
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
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