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The Benefits of Transcranial Photobiomodulation in Lewy Body Disease

NCT07602296 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-22

No results posted yet for this study

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

Interventions

DEVICE

photobiomodulation using the medical 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).

DEVICE

no photobiomodulation using the medical device

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

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-12-31
Completion
2029-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07602296 on ClinicalTrials.gov