Transcranial Photobiomodulation in Dementia with Lewy Bodies: A Proof-of-Concept Sham-Controlled Trial (W-0929)

Methodology for a randomized proof of concept study on the effect of transcranial PBM on clinical symptoms, quality of life, and brain connectivity in DLB.

Dementia with Lewy Bodies (DLB) is the second most common progressive neurocognitive disorder after Alzheimer’s disease1

Photobiomodulation (PBM) involves applying red to infrared light (λ=600-1000nm) to body tissues

Light absorption by photoreceptors located in the mitochondria ↑ energy production (ATP)

Can penetrate up to 30-50mm in some brain regions2

Positive results were seen in Alzheimer’s and Parkinson’s disease3,4

Early-stage DLB: cortically located pathology and characterized by synaptic dysfunction rather than cell death5, therefore PBM has a high potential for clinical and symptomatic effects.

Objectives: To explore the effect of PBM on clinical symptoms, quality of life, and brain connectivity in patients with DLB after 3 and 6 months of twice daily PBM sessions, as well as one month post intervention for any remanent effect.

Randomized, double-blind, sham-controlled, proof-of-concept trial.

Study setting: CM2R, Strasbourg University Hospital Center (Strasbourg, France)

 

Participants : N=30

> 50 years old, probable or prodromal DLB  MMSE score ≥ 18/30

Presence of a daily caregiver  Head circumference 54-62cm

 

Study procedure: (see figure 1)

2x daily at-home PBM or sham sessions, 32 minutes each, for 6 months

In person home visits every two weeks

Phone calls every other week to monitor participants’ well-being, assess for potential adverse events, assess device functionality, and monitor adherence to the study protocol.

 

Material:

LUCIOLE Cap, a non-invasive LED device delivers transcranial PBM (λ=810nm)

Total illumination power of up to 8W (approximately 40mW/cm²)

The sham caps are visually identical to the active PBM caps, but do not deliver PBM

 

Evaluations & Analysis:

Comprehensive neuropsychological assessments (e.g. RBANS, MoCA), clinical and neurological examinations (e.g. Time up and go, physical exam), symptom questionnaires

Multimodal MRI (VBM, functional connectivity)

Group comparison: transversal and longitudinal comparisons

Correlation analyses between MRI measures and clinical variables