Could a light helmet ease lewy body dementia?
NCT ID NCT07602296
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special helmet that shines near-infrared light on the brain (called transcranial photobiomodulation) in 40 people with Lewy body dementia. Participants use the helmet twice daily for 6 months. Researchers will check thinking skills, symptoms, and quality of life before and after treatment. The goal is to see if this light therapy can help with memory, attention, and daily function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LUCIOLE Cap (a non-invasive helmet that shines near-infrared light on the brain)
- What this could lead to
- If it works, this could point toward a non-drug way to ease thinking and daily-life problems in Lewy body dementia.
- What could go wrong
- This is a very early, small trial (40 people) testing a device that has never been used in humans before. It may not work or could cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * Man or woman, 50 years or older * Probable DLB diagnosed according to the criteria of McKeith et al., 2017, or the criteria of McKeith et al., 2020 for prodromal DLB * Score on the Mini Mental State Examination (MMSE; Folstein et al., 1983) ≥ 18/30 at their last medical visit * Good mastery of the French language * Accompanied by a caregiver or a person able to provide information about them (interview, by telephone). * Able to understand the objectives and risks associated with the research and to give informed consent, dated and signed * Covered by a social health insurance plan * Having a head circumference between 54 and 62 cm. Exclusion criteria: * Not able to understand the objectives and risks related to research and to give informed consent * Presence of another neurological disorder, including but not limited to brain tumors, stroke with potential cognitive impairment, or diagnosis of another progressive neurological disease (e.g., Alzheimer's disease, Parkinson's disease, etc.), and as determined by the investigator * Having an MMSE score \< 18 at the screening visit * Unable to undergo a brain MRI due to medical reasons * Participants whose follow-up would likely be disrupted during the study period (e.g., due to planned relocation or other reasons) * Insufficient proficiency of the French language * Participants experiencing an emergency of life-threatening situation * Alone, without a caregiver present * Participants presenting with a head/scalp injury * Participants with a silicone allergy * Participants with cranial/skull shape abnormalities * Participants with a head circumference outside the range of 54-62 cm * Participants requiring life support, continuous monitoring, and/or implanted medical devices (AIMD) * Participants taking the antiepileptic Keppra (Levetiracetam) * Participants whose anticholinesterase treatments have been changed within the past 2 months * Participants whose antipsychotic treatments have been changed within the last 15 days * Pregnant or breastfeeding women
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000, France
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