Intracerebral Optical Device
Slowing down Parkinson’s disease
using intracranial photobiomodulation,
ie “light medicine into the brain”
CEA-Leti’s clinical trial aims to slow down neurodegeneration using an intracerebral device which generates an emission of a neuro-protecting light. Current treatments for Parkinson’s disease temporarily mitigate symptoms. The therapeutic effects of photobiomodulation have been demonstrated in rodent and non-human primate models of Parkinson’s disease. CEA-Leti's clinical trial aims, in particular, to prove the feasibility, safety and their effectiveness in humans.
How does it work?
NIR technology has three components:
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a 2.5 cm-diameter optical unit containing electronics and a laserphotodiode emitting at 670 nm. This is inserted into the cranial cavityinstead of bone material.
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fiber optics that transport light near the brain’s substantia nigra(structures that degenerate with Parkinson’s disease). For minimallyinvasive surgery, the fiber is primarily inserted through the ventricles.
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a Boston Scientific
stimulator, customized by the firm to fit CEA-Leti’soptical module specifications, and surgically implanted underthe collarbone
The optical unit were developed by CEA-Leti, then manufactured, assembled, and characterized in its clean rooms. The clinical trial patients (Ev-NIRT, driven by Grenoble University Hospital) were implanted at CLINATEC, the CEA-Leti biomedical research center, equipped with a clinical sector with an operating room.
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What's new?
- First therapeutic approach based on intracranial photobiomodulation,expected to slow down the evolution of Parkinson’s disease. Currenttreatments are only symptomatic
- First intracerebral application of light’s therapeutic effects for Parkinsons’ disease
- First clinical trial using intracranial light for Parkinsons’disease in the worldon 14 patients launched early 2021
- Development, manufacturing, characterization, and patient implantsentirely performed at CEA-Leti for the optical part.
| What's next?
By 2026, end of the first clinical trial (7 implanted patients, 7 control patients), essentially geared toward device safety and the non-toxicity of light. If successful, launch of a multi-center clinical trial, which will be essentially focused on the therapeutic effectiveness of NIR technology.
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Publications
Near-infrared light is neuroprotective in a monkey model of Parkinson disease. Darlot F, Moro C, El Massri N, Chabrol C, Johnstone D, Reinhart F, Agay D, Torres N, Bekha D, Auboiroux V, Costecalde T, Peoples CL, Anastascio HD, Shaw V, Stone J, Mitrofanis J, Benabid AL. Ann Neurol. 2016 Jan; 79(1):59-75.
Réf. clinicaltrial.com >NCT04261569
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