NCT04261569Active, not recruiting
Clinical Trial for Near Infrared Endoventricular Illumination for Neuroprotection in Very Early Cases of Parkinson's Disease (Ev-NIRT)
Source: ClinicalTrials.gov · Last updated 1 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 27 Jan 2020
- Start date
- 14 Dec 2020
- Primary completion date
- Jan 2029
- Lead sponsor
- University Hospital, Grenoble
- Diseases
- Parkinson disease
- NCT number
- NCT04261569
What you commit to
- Study type: Interventional
- Planned participants: 14
- From 14 Dec 2020 to the primary completion date, Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Carcinological history in the previous 5 years, not stabilized
- Surgical or anesthetic contraindication
- Predictable need for frequent use of MRI scans after surgery
- Chronic treatment with L-Dopa or dopamine agonist
Other illness
- 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
- Uncontrolled medical condition that may lead to complications
- 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)
- History of brain infection with herpes virus
- Patient with cognitive impairment at the outset of illness (Montreal Cognitive Assessment (MoCA) score - 26)
- Atypias suspecting atypical Parkinson's syndrome
Other
- Contraindication to MRI (claustrophobia, non-compatible mri metal prosthesis, etc.)
- Unstabilized psychotropic treatment
- Presence of another serious pathology (major depressive episode, suicidal patient, active psychosis ...)
- Participation in another interventional clinical trial
- Wearing pace makers other than brain
Who the study is looking for
- Clinically diagnosed idiopathic Parkinson's disease according to MDS criteria developed by R.B. Postuma (Anang et al, Neurology, 2014)
- 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
- Patients willing to start dopaminergic treatment
- Very early stage of the disease:
- Diagnosis of recent Parkinson's disease (less than two years after a neurologist's diagnosis)
- Hoehn and Yahr Stage 1 to 2
- Maximum 2 tremor on the MDS-UPDRS scale
- Naive of any anti-Parkinsonian treatment
- Between 25 and 65 years of age
- Score on Beck Depression Inventory (BDI) scale below the value of 20
- Easy handling of the French language in oral and written language
- Social security affiliates or beneficiaries of such a scheme
- Informed and written consent signed by the patient
Age in the registry: 25 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CLINATEC Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.