The Benefits of Transcranial Photobiomodulation in Lewy Body Disease (LEWY-LIGHT)

The Benefits of Transcranial Photobiomodulation on Clinical Symptoms, Quality of Life and Changes in Brain Connectivity in Lewy Body Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lewy Bodies Disease
• Intervention / Treatment: Device: photobiomodulation using the medical device; Device: no photobiomodulation using the medical device

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frédéric Professor BLANC, Professor; Phone Number: +33 3 88 11 56 24; Email: frederic.blanc@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67000
    • Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men or women aged 50 or over
2. Diagnosed with probable MCL according to the criteria of McKeith et al., 2017, or the criteria of McKeith et al.

2020 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

Exclusion Criteria:

• 1. Unable to understand the objectives and risks associated with the research and to give informed consent 2. Presenting with another neurological condition, including but not limited to the following: brain tumour, established stroke that may lead to cognitive impairment, other progressive neurological disease, and at the investigator's discretion 3. With an MMSE score < 18 at the inclusion visit 4. With a contraindication to brain MRI 5. Whose follow-up would be compromised during the study period (planned move, etc.) 6. Not sufficiently proficient in the French language 7. In an emergency or life-threatening situation 8. Alone, without a carer present 9. With a head injury (skull surface) 10. With a silicone allergy 11. With an atypical skull shape 12. With a head circumference outside the range [54-62 cm] 13. Requiring the use of life-support, monitoring and/or implanted medical devices with ICDs 14. Patients taking the anti-epileptic drug Keppra (Levetiracetam) 15. Patients whose anticholinesterase treatments have been changed within the last 2 months 16. Patients whose neuroleptic treatments have been changed within the last 15 days 17. Pregnant or breastfeeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active device; This group will receive photobiomodulation treatment using the medical device	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).
Placebo Comparator: Placebo device; This group will not receive photobiomodulation treatment using the medical device	Device: no photobiomodulation using the medical device; The placebo helmet will look similar to the active helmet, but will not deliver photobiomodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Randomization; transcranial photobiomodulation; Lewy body disease (LBD); non-invasive medical device
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Lewy Body Disease
• Other Study ID Numbers: 9609

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No