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ACTIVE NOT RECRUITING

NCT04261569

Clinical Trial for Near Infrared Endoventricular Illumination for Neuroprotection in Very Early Cases of Parkinson's Disease (Ev-NIRT)

Sponsor: University Hospital, Grenoble

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-12-14

Completion Date

2032-04

Last Updated

2025-04-01

Healthy Volunteers

Conditions

Very Early Stage of Parkinson's Disease

Interventions

DEVICE

Ev-NIRT

Endoventricular near infra red treatment : Intraventricular pulsed, chronic, cyclic, near-infrared illumination of the Central Nervous System (CNS) at 150 Hz, 15 mW, 1 minute ON and 5 minutes OFF

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

Locations (1)

CLINATEC

Grenoble, France