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

NCT07602296 | Not Yet Recruiting

• 1 other identifier: 9609
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Photobiomodulation; Dementia With Lewy Bodies

Keywords

Photobiomodulation (PBM); Dementia with Lewy bodies (DLB); Cognitive functions; Clinical symptoms; Quality of life; Cerebral connectivity

Outcome Measures

Primary Outcomes (1)

• Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  (Randolph et al., 1998)

  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)

Study Arms (2)

Active

EXPERIMENTAL

The participants assigned to the active group will each receive an active LUCIOLE cap to be used at home twice daily for six months with the assistance of their caregiver. A minimum interval of four hours is required between the two daily sessions. Each session lasts for 32 minutes (including 24 minutes of active near-infrared red light and 8 minutes of cooling periods spaced throughout the session). The cap automatically turns off at the end of each session. The caregiver assists the participant in placing the cap on correctly, verifies that the cap works properly, and starts the session. All participants in the active group will undergo neuropsychological evaluations, clinical and neurological examinations, MRIs, and blood tests and at months 0, 3 and 6 of the study. Participants will also be evaluated at month 7, one month after the end of the photobiomodulation sessions, during which the same clinical, neurological and neuropsychological evaluations will be administered.

Device: LUCIOLE CAP

Sham

SHAM COMPARATOR

Participants in the sham group will follow the same PBM schedule as the participants in the active group: twice daily sessions of 32 minutes for six months (see active group description for more information) except they will use the sham LUCIOLE cap. The sham cap mimics the appearance, heating and operation of the active cap but does not deliver PBM. The only difference between the two versions is in the internal electronics and firmware modifications. The two versions can only be differentiated by their serial numbers. All participants in the study, as well as the research team, do not know which caps are active and which are sham. As in the active group, participants in the sham group will undergo neuropsychological evaluations, clinical and neurological examinations, MRIs, and blood tests and at months 0, 3 and 6 of the study. Participants will also be seen at month 7, one month after the end of the PBM sessions, for clinical, neurological and neuropsychological evaluations.

Device: LUCIOLE CAP (sham version)

Interventions

LUCIOLE CAP DEVICE

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.

Active

LUCIOLE CAP (sham version) DEVICE

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.

Sham

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 may not qualify 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Lewy Body Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Frédéric Professor BLANC, Professor

CONTACT

+33 3 88 11 56 24; frederic.blanc@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Doctoral student conducting the study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

FR (1)