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Could a light helmet ease lewy body dementia?

NCT ID NCT07602296

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

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

50 years and older

Sex

Anyone

Healthy volunteers

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

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.

Lewy body dementia Lewy Body Disease

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67000, France

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