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

NCT04261569 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Grenoble

Phase

Not applicable

Started

2020-12-14

Last updated

2025-04-01

Condition(s) studied

Very Early Stage of Parkinson's Disease

Investigational drug(s) / intervention(s)

Ev-NIRT

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

Study 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.

Eligibility

Sex

ALL

Min age

25 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Incidence of Ev-NIRT Treatment on Emergent Adverse Events (Tolerance) after surgical intervention and NIR illumination following the implantation of the Ev-NIRT medical device — 4 years
Emergent Adverse Events \[Safety and Tolerability\]

Trial sites (1)

Facility	City	Region	Status
CLINATEC	Grenoble	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04261569 on ClinicalTrials.gov ↗ ← All trials in France