Red-light helmet therapy for people with dementia with Lewy bodies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses a helmet with small LEDs to deliver red-light therapy to adults with probable or prodromal DLB. Participants will receive active treatment or a sham version to compare effects on cognitive function, clinical symptoms, quality of life, and brain connectivity. Outcomes focus on whether this therapy can produce measurable improvements and how it affects brain networks. The trial is conducted at Strasbourg University Hospital with adults aged 50 and older who have a caregiver and meet language and consent criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpitaux Universitaires de Strasbourg
  Strasbourg, France Recruiting

Study contacts

• Study coordinator: Frédéric Professor BLANC, Professor
• Email: frederic.blanc@chru-strasbourg.fr
• Phone: +33 3 88 11 56 24

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.