It is not very becoming, but it is comfortable: the Luciole photobiomodulation helmet intended to be tested in several clinical trials in the coming months was presented to the public by the Clinatec fund. The object more or less resembles a blue rugby helmet, housing a set of LEDs aimed at the user’s skull. The light used, whose wavelength is close to infrared (810 nm), diffuses through the skull bone with the aim of activating the energy metabolism and ATP production of cortical neurons.
Researchers from Clinatec, an endowment fund backed by the CEA and the CHU Grenoble Alpes, hope that photobiomodulation can have a positive effect on the trajectory of patients suffering from neurodegenerative pathologies, such as Lewy body disease, for which a clinical study will be launched from 1is mars 2026.
The Clinatec fund has made a specialty of the use of light stimulation in neurology: since 2024, the teams of Professor Stephan Chabardes, head of the neurosurgery department at Grenoble Alpes University Hospital, have transplanted 6 patients suffering from Parkinson’s disease with a device delivering light pulsations directly into the dopaminergic basal ganglia. But this time, it is an external stimulation, which can be done at home. Thirty patients will be recruited from the active group of Professor Frédéric Blanc’s geriatrics department, at the Strasbourg university hospitals. Half of them will receive the Luciole and the other will receive helmets which simulate photobiomodulation sequences (the device heats up slightly but does not emit light).
The recruited patients, all aged at least 50 years, will be “at the prodromal stage, with an MMS (Mini-Mental State Examination) score greater than 18. They must also have a positive Datscan SPECT scan”, complete Sara Illick neuropsychologist leading a thesis on photobiomodulation in Lewy body disease. However, this examination is not enough. “A positive result can also be observed in patients with Parkinson’s disease, she continues. Therefore, the diagnosis of Lewy body disease requires clinical examinations to be confirmed, such as polysomnography for example..
Marketing expected within 4 to 5 years
Several 32-minute sessions, including 24 minutes of illumination, will be scheduled each week for 6 months. Patients will be followed for an additional month to measure possible long-term effects. The results are expected within 4 to 5 years, with the Clinatec fund hoping to have a commercial version available shortly after.
The evaluation criteria will be: measurement of cognition through neurological tests, evaluation of executive functions, memory, autonomy and quality of life. MRI scans will be performed to look for possible changes in neuroanatomy. Clinatec researchers do not rule out carrying out future studies on the preventive use of photomodulation. The idea is still in development, but “this could be a study on asymptomatic people whose blood markers raise fears of the appearance of Lewy body disease”predicts Sara Illick.
Helmets given to participants “are as simple as possible, a simple button turns it on and off automatically”explains Antoine Robinet, electronics engineer and project manager of the Clinatec fund. However, only patients with a caregiver at home will be recruited, responsible for ensuring correct daily use. The headset is equipped with a chip to ensure real-time monitoring of sessions by researchers. Patients also have a telephone application to assist them in their treatment. The protocol and the helmet were validated by the National Medicines Safety Agency (ANSM) in December. “We have done several studies on the diffusion and propagation of light in the brain, completes Antoine Robinet. Our device meets the requirements of the ISO 60601 standard »the standard for medical devices.
Six studies and 150 helmets produced in 2026
Four other studies are planned with this first helmet prototype: one on Alzheimer’s disease, in partnership with the Hospices Civils de Lyon (HCL) and three others on recovery after head trauma, with the HCL and the CHU Grenoble Alpes. The Clinatec fund plans to manufacture 150 helmets in 2026 (the device is built by two companies located in Annecy and Grenoble) and a new version is planned for that same year, based on initial feedback from users.
The concept of the Clinatec fund’s photobiomodulation helmet finds its origins in the work carried out since 2008 by John Mitrofanis, a professor who has since become scientific director of the Clinatec fund. In 2014, the researcher, at the time a member of the Bosch Institute at the University of Sydney, published a promising preclinical study on a mouse model of Alzheimer’s disease with a reduction at 4 weeks in the number of beta amyloid plaques. “ We hope for the same result in those with Lewy body disease who may also present with such lesions”adds Sara Illick.
In 2023, he had conducted a systematic review of the literature which concluded that transcranial photobiomodulation can modulate brain activity in humansby increasing cerebral blood flow and functional connectivity. However, according to a another systematic review of the literature in 2002, photobiomodulation reduced brain inflammation and oxidative stress in animal models of neurodegenerative diseases, resulting in neuroprotection. Between 600 and 1300 nm, light stimulates mitochondria and increases ATP production. This extra energy “increases the capacity of cells to fight against stress and neurodegenerative pathologies”says Laurent Herault, director of the Clinatec fund.
In Montpellier, another helmet evaluated in Alzheimer’s disease by RegenLife
Clinatec is not the only entity in France to experiment with photobiomodulation in the indication of neurological pathologies. In Montpellier, after a first encouraging randomized trial, the RegenLife company is financing a clinical trial in Alzheimer’s disease for its own device, the RgN 600. Here, the particularity is that the light is not only applied to the cortex, but also to the abdominal region, using LEDs attached to a strap. “There is a link between the brain and the intestine, which is involved in many disorders including Alzheimer’s disease, explains Professor Jacques Touchon, former director of the neurology department at Montpellier University Hospital and member of the RengenLife scientific team. We noticed in an animal model that photobiomodulation treatment is better if we act on both ends of this axis. »
“There are still few investigations in neurology on the abdominal girdlerecognizes Professor Touchon. What we are sure of is that the action of near-infrared light on the mitochondria will bring a halt to the vicious neuro-inflammatory circle. »
The treatment is administered in hospital, 108 patients with mild to moderate Alzheimer’s will be treated for six months. Finally, six months of additional follow-up will be used to evaluate longer-term effects. Already 69 patients have been recruited at the Toulouse University Hospital, the Lariboisière hospital and the Broca hospital (Paris), with the study scheduled to end in 2026.
RegenLife is counting on this data to prepare a registration file as a medical device in Alzheimer’s disease, after a first application submitted for the treatment of head trauma in December 2025, following a study carried out in concussed athletes (results not yet published). Other indications are considered such as depression and intestinal dysbiosis.
date:2026-02-11 13:31:00
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