NCT07602296 · NOT YET RECRUITING
Evaluating How Red-light Therapy Applied to the Head Affects Symptoms, Daily Life, and Brain Activity in People With Dementia With Lewy Bodies
This trial tests whether wearing a helmet with small red LED lights, twice a day for six months, affects thinking, symptoms, quality of life, and brain connectivity in people with dementia with Lewy bodies. Some participants get a sham (inactive) helmet for comparison. It is not a drug phase study, so there is no phase label, and it is not proven.
You may qualify if
- 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.
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-06-23