Evaluating How Red-light Therapy Applied to the Head Affects Symptoms, Daily Life, and Brain Activity in People With Dementia With Lewy Bodies

Condition(s) studied

Investigational drug(s) / intervention(s)

LUCIOLE CAP: The LUCIOLE Cap is a medical device (without CE mark) designed for transcranial photobiomodulation (PBM). The cap was developed specifically for this purpose by the CLINATEC Endowment Fund (FDC), and it has not been used in any clinical investigation before. The LUCIOLE Cap will be used for the first time in this study with patients diagnosed with Dementia with Lewy bodies. The LUCIOLE cap is a non-invasive device that delivers PBM to the brain by shining light through the skin and bone. The LEDs emit near-infrared-light at a wavelength of 810 nm, with an illumination power of up to 8W (\~40mW/cm²). For safety, the cap must only be used in the room chosen by the study investigator during the first home visit. It must be used in a dry environment, away from sources of water or moisture, avoiding direct sunlight, and at a room temperature between 5°C and 27.5°C.

LUCIOLE CAP (sham version): The CLINATEC Endowment Fund (FDC) designed this sham cap exclusively for scientific studies. It is built specifically to provide an accurate comparison against the active cap. This precise control allows investigators to clearly evaluate whether the active LUCIOLE cap delivers true, measurable benefits. The sham cap mimics the active LUCIOLE cap's operational characteristics and heat output without delivering actual PBM. The devices look identical and are distinguishable only by their serial numbers. This internal difference in electronics and firmware guarantees that both clinical investigators and participants remain blinded to the treatment allocation. For safety, the cap must only be used in the room chosen by the study investigator during the first home visit. It must be used in a dry environment, away from sources of water or moisture, avoiding direct sunlight, and at a room temperature between 5°C and 27.5°C.

Study summary

Dementia with Lewy bodies (DLB) is a neurodegenerative disease diagnosed primarily based on the presence of cognitive decline, which may include difficulties with memory, attention, and more. Additionally, at least two of the following symptoms are needed for a probable diagnosis of DLB, and at least one for a possible DLB diagnosis (McKeith et al. 2017 and 2020):

* Fluctuations in cognition, attention, and/or alertness
* Visual hallucinations
* Spontaneous parkinsonism
* REM sleep behavior disorder

Patients with DLB can experience cognitive deficits that can fluctuate and can vary for each patient. These may include deficits in memory, executive functions (planning and organizing), attention, visual processing, and language.

This study aims to evaluate the effect of red-light therapy, delivered using a helmet that contains small LED lights, in patients with DLB.

Participants' cognitive functions, clinical symptoms, quality of life and functional cerebral connectivity will be evaluated before starting therapy and again after three and six months of twice daily therapy use. As DLB also indirectly affects caregivers, the caregiver's quality of life and burden will also be evaluated before and at three and six months of therapy use by the participant.

The study's inclusion period is 24 months and the duration of participation for each patient is 8 months (+/-10 days) maximum.

Eligibility

Primary outcome measure(s)

• Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) — Measurements done right before start of PBM (at month 0 (M0)), after 3 months of PBM (M3), after six months of PBM (M6), and one month after end of PBM (M7)
  (Randolph et al., 1998)

Trial sites (1)

More University Hospital, Strasbourg, France trials in France

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