PhotobiomodulationLewyLIGHTNCT07602296
Evaluating How Red-light Therapy Applied to the Head Affects Symptoms, Daily Life, and Brain Activity in People With Dementia With Lewy Bodies
A study testing LUCIOLE CAP in people with Photobiomodulation and Dementia With Lewy Bodies, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Photobiomodulation, Dementia With Lewy Bodies
- What is being tested?
- LUCIOLE CAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Transcranial Photobiomodulation on Clinical Symptoms, Quality of Life and Cerebral Connectivity Modifications in Dementia With Lewy Bodies
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
Read more
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.
Read the detailed description
Dementia with Lewy bodies (DLB) is the second most frequent neurodegenerative disease after Alzheimer's disease and represents 15 to 20% of dementia cases (Ballard et al. 2001; Zaccai et al. 2005; Aarsland et al. 2008). DLB is diagnosed primarily based on the presence of cognitive decline, which is most often perceived as difficulties relating to attention, visuospatial capacities and executive functions like planning, decision making and more.
Additionally, at least two of the following core clinical 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
Suggestive symptoms may support the diagnosis of probable DLB when at least one core clinical symptom is present together with one of the following features, or possible DLB when one or more of the following features are present in the absence of any core clinical feature (McKeith et al. 2017 and 2020):
- Severe sensitivity to neuroleptics
- Postural instability
- Recurrent falls
- Syncope or transient episodes of responsiveness
- Severe autonomic dysfunction: constipation, urinary incontinence, etc.
- Hallucinations in other sensory modalities (ex. auditory)
- Delusions
- Apathy, anxiety, depression
- Reduced dopamine transporter uptake in basal ganglia on DAT scan
- Abnormal cardiac I-MIBG scintigraphy (reduced myocardial MIBG uptake)
- MRI or CT: relative preservation of medial temporal lobe structures
- SPECT or PET: reduced tracer uptake with occipital hypometabolism
- EEG: prominent posterior slow wave activity with periodic fluctuations in the pre-alpha/theta range
There is currently no treatment for DLB (Mueller et al. 2017). The effectiveness of available symptomatic treatments is also limited and sometimes accompanied by severe side effects (Boot et al. 2013; Boot, 2015). There is therefore an urgent need to develop therapeutic solutions adapted to DLB, aiming at neuroprotection and/or improvement of the quality of life of patients through better management of clinical symptoms. We are particularly interested in non-invasive and non-pharmacological approaches, with the aim of identifying methods without side effects and can easily be used by patients daily.
In this context, a new approach is the subject of growing interest within the medical and scientific communities, as well as the general public. Known as photobiomodulation (PBM), this technique involves applying red to infrared light (λ=600-1000nm) on biological tissues.
This study aims to evaluate the effect of transcranial PBM in patients with DLB.
Participants' cognitive functions, clinical symptoms, quality of life and 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.
- Conditions
- Photobiomodulation, Dementia With Lewy Bodies
- Being tested
- LUCIOLE CAP, LUCIOLE CAP (sham version)
- Keywords
- Photobiomodulation (PBM), Dementia with Lewy bodies (DLB), Cognitive functions, Clinical symptoms, Quality of life, Cerebral connectivity
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUCIOLE CAPDevice
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: LUCIOLE CAP (sham version) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
(Randolph et al., 1998)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotobiomodulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602296
- Sponsor's protocol ID
- 9609
- Acronym
- LewyLIGHT
- Status last verified
- Jun 2026
- First submitted
- 15 May 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Photobiomodulation on Clinical Symptoms, Quality of Life and Cerebral Connectivity Modifications in Dementia With Lewy Bodies
- ClinicalTrials.gov ID
- NCT07602296
- Acronym / sponsor ID
- LewyLIGHT / 9609
- Conditions
- Photobiomodulation, Dementia With Lewy Bodies
- Keywords
- Photobiomodulation (PBM), Dementia with Lewy bodies (DLB), Cognitive functions, Clinical symptoms, Quality of life, Cerebral connectivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dementia with Lewy bodies (DLB) is the second most frequent neurodegenerative disease after Alzheimer's disease and represents 15 to 20% of dementia cases (Ballard et al. 2001; Zaccai et al. 2005; Aarsland et al. 2008). DLB is diagnosed primarily based on the presence of cognitive decline, which is most often perceived as difficulties relating to attention, visuospatial capacities and executive functions like planning, decision making and more.
Additionally, at least two of the following core clinical 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
Suggestive symptoms may support the diagnosis of probable DLB when at least one core clinical symptom is present together with one of the following features, or possible DLB when one or more of the following features are present in the absence of any core clinical feature (McKeith et al. 2017 and 2020):
- Severe sensitivity to neuroleptics
- Postural instability
- Recurrent falls
- Syncope or transient episodes of responsiveness
- Severe autonomic dysfunction: constipation, urinary incontinence, etc.
- Hallucinations in other sensory modalities (ex. auditory)
- Delusions
- Apathy, anxiety, depression
- Reduced dopamine transporter uptake in basal ganglia on DAT scan
- Abnormal cardiac I-MIBG scintigraphy (reduced myocardial MIBG uptake)
- MRI or CT: relative preservation of medial temporal lobe structures
- SPECT or PET: reduced tracer uptake with occipital hypometabolism
- EEG: prominent posterior slow wave activity with periodic fluctuations in the pre-alpha/theta range
There is currently no treatment for DLB (Mueller et al. 2017). The effectiveness of available symptomatic treatments is also limited and sometimes accompanied by severe side effects (Boot et al. 2013; Boot, 2015). There is therefore an urgent need to develop therapeutic solutions adapted to DLB, aiming at neuroprotection and/or improvement of the quality of life of patients through better management of clinical symptoms. We are particularly interested in non-invasive and non-pharmacological approaches, with the aim of identifying methods without side effects and can easily be used by patients daily.
In this context, a new approach is the subject of growing interest within the medical and scientific communities, as well as the general public. Known as photobiomodulation (PBM), this technique involves applying red to infrared light (λ=600-1000nm) on biological tissues.
This study aims to evaluate the effect of transcranial PBM in patients with DLB.
Participants' cognitive functions, clinical symptoms, quality of life and 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: LUCIOLE CAPThe 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. |
| Sham | Sham comparator | Device: LUCIOLE CAP (sham version)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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUCIOLE CAPThe 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. | Device | Active |
| 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. | Device | Sham |
Primary outcome
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LUCIOLE CAP in people with Photobiomodulation and Dementia With Lewy Bodies, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédéric Professor BLANC, Professor (+33 3 88 11 56 24, frederic.blanc@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.