Evaluating How Red-light Therapy Applied to the Head Affects Symptoms, Daily Life, and Brain Activity in People With Dementia With Lewy Bodies (LewyLIGHT)
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
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Frédéric Professor BLANC, Professor
- Número de teléfono: +33 3 88 11 56 24
- Correo electrónico: frederic.blanc@chru-strasbourg.fr
Ubicaciones de estudio
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Strasbourg, Francia, 67000
- Hopitaux Universitaires de Strasbourg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Active
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. |
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. |
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Comparador falso: Sham
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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Periodo de tiempo: 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)
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(Randolph et al., 1998)
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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)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Sinucleinopatías
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Trastornos neurocognitivos
- Demencia
- Enfermedades neurodegenerativas
- Trastornos del movimiento
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Enfermedad de cuerpos de Lewy
Otros números de identificación del estudio
- 9609
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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