The Benefits of Transcranial Photobiomodulation in Lewy Body Disease

NCT07602296 | Not Yet Recruiting

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

Brief Summary

Lewy body disease (LBD) is the second leading cause of progressive neurodegenerative dementia. Characterised by a complex clinical picture combining cognitive, motor and behavioural symptoms, it is subject to a high rate of misdiagnosis and lacks a fully effective curative or symptomatic treatment. The LEWY-LIGHT project aims to evaluate, for the first time in LBD, an innovative non-pharmacological approach: transcranial photobiomodulation (PBM). This non-invasive and safe technique uses red/infrared light to stimulate brain cell activity and improve higher cognitive functions, building on already promising results obtained in Alzheimer's and Parkinson's diseases.

Conditions

Lewy Bodies Disease

Keywords

Lewy body disease (LBD); non-invasive medical device; Randomization; transcranial photobiomodulation

Outcome Measures

Primary Outcomes (1)

• Composite Cognitive Score on the RBANS

  Comparison of the composite cognitive score on the RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) between patients in the experimental group and those in the placebo group at 6 months.

  6 months

Study Arms (2)

Active device

EXPERIMENTAL

This group will receive photobiomodulation treatment using the medical device

Device: photobiomodulation using the medical device

Placebo device

PLACEBO COMPARATOR

This group will not receive photobiomodulation treatment using the medical device

Device: no photobiomodulation using the medical device

Interventions

photobiomodulation using the medical device DEVICE

The active headset will deliver wavelengths corresponding to 810nm photobiomodulation (clear, near infrared) over a 24-minute period at a fixed frequency of 40Hz, with an additional 8-minute break during each treatment (totalling 32 minutes per treatment).

Active device

no photobiomodulation using the medical device DEVICE

The placebo helmet will look similar to the active helmet, but will not deliver photobiomodulation

Placebo device

Eligibility Criteria

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

You may qualify if:

• Men or women aged 50 or over
• Diagnosed with probable MCL according to the criteria of McKeith et al., 2017, or the criteria of McKeith et al.
• for prodromal MCL 3. Score on the Mini Mental State Examination (MMSE; Folstein et al., 1983) ≥ 18/30 at their last medical visit (prodromal stage or major neurocognitive disorder stage (mild dementia syndrome) 4. Good command of the French language 5. Accompanied by a carer or a person able to provide information about them (interview, telephone contact). 6. Able to understand the objectives and risks associated with the research and to provide informed consent dated and signed 7. Enrolled in a statutory health insurance scheme 8. With a head circumference between 54 and 62 cm

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

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

Record last verified: 2026-05

Locations

FR (1)