Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
Study NCT ID:
NCT04261569
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-01
First Post:
2020-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial for Near Infrared Endoventricular Illumination for Neuroprotection in Very Early Cases of Parkinson's Disease (Ev-NIRT)
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Clinical Trial for Near Infrared Endoventricular Illumination for Neuroprotection in Very Early Cases of Parkinson's Disease (Ev-NIRT)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ev-NIRT
Brief 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.
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.
Detailed Description:
The level of neuroprotection induced by illumination at 670nm appears effective in preclinical studies, and justify the transfer into a clinical trial. The investigators currently have developed and produced implantable devices, to be implanted into the brain through a minimally invasive endoventricular route. The electrical energy required is supplied by the batteries adapted from those used for deep brain stimulation.
The feasibility of trans ventricular implantation is ensured by the experience gained by our team in the endoventricular stimulation of the posterior hypothalamus in the cluster headache.
In this clinical study, the investigators will evaluate the tolerance and safety of intraventricular surgical technic and illumination by the Ev-NIRT medical device implanted into the brain of 7 patients with Parkinson's disease. idiopathic, aged 25-65 years, at a very early stage (less than 2 years of evolution). The NIR illumination will begin immediately after surgery.
The investigators will also evaluate secondarily, the neuroprotective effect of this new treatment modality, by comparing the decrease of dopaminergic neurons by Positron Emission Tomography (PET)-scan using \[11C\]PE2I) tracer of implanted patients to that of a control group of 7 patients whose characteristics in terms of duration of evolution and clinical severity are identical, but who are not implanted, and therefore not exposed to NIR illumination.
The PET-scan-PE2I exam is conducted in both groups annually for 4 years (a total of 5 measurements) and compared to the PE2I PET obtained at the beginning of participation in the study. A group-wide comparison will be made between the NIR group and the control group.
The feasibility of trans ventricular implantation is ensured by the experience gained by our team in the endoventricular stimulation of the posterior hypothalamus in the cluster headache.
In this clinical study, the investigators will evaluate the tolerance and safety of intraventricular surgical technic and illumination by the Ev-NIRT medical device implanted into the brain of 7 patients with Parkinson's disease. idiopathic, aged 25-65 years, at a very early stage (less than 2 years of evolution). The NIR illumination will begin immediately after surgery.
The investigators will also evaluate secondarily, the neuroprotective effect of this new treatment modality, by comparing the decrease of dopaminergic neurons by Positron Emission Tomography (PET)-scan using \[11C\]PE2I) tracer of implanted patients to that of a control group of 7 patients whose characteristics in terms of duration of evolution and clinical severity are identical, but who are not implanted, and therefore not exposed to NIR illumination.
The PET-scan-PE2I exam is conducted in both groups annually for 4 years (a total of 5 measurements) and compared to the PE2I PET obtained at the beginning of participation in the study. A group-wide comparison will be made between the NIR group and the control group.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-A02097-50 | OTHER | ANSM ID RCB | View |