| Field | Value | |-------|-------| | NCT Number | [NCT07271927](https://clinicaltrials.gov/study/NCT07271927) | | Status | Recruiting | | Sponsor | Pusan National University Yangsan Hospital | | Phase | Not applicable (device trial) | | Start Date | February 2025 | | Completion Date | December 2025 |
Intervention
Type: Device — Photobiomodulation (PBM)
Description: Whole-body photobiomodulation therapy applied approximately 10 weeks (three sessions per week, once daily, 20 minutes per session)
Mechanism
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Whole-Body Photobiomodulation for Motor and Cognitive Changes in Parkinson's Disease
Trial Overview
Mermaid diagram (expand to render)
| Field | Value | |-------|-------| | NCT Number | [NCT07271927](https://clinicaltrials.gov/study/NCT07271927) | | Status | Recruiting | | Sponsor | Pusan National University Yangsan Hospital | | Phase | Not applicable (device trial) | | Start Date | February 2025 | | Completion Date | December 2025 |
Intervention
Type: Device — Photobiomodulation (PBM)
Description: Whole-body photobiomodulation therapy applied approximately 10 weeks (three sessions per week, once daily, 20 minutes per session)
Mechanism
[Photobiomodulation](/therapeutics/photobiomodulation-therapy) (also known as low-level light therapy) uses red or near-infrared light to stimulate cellular processes. The proposed mechanisms in Parkinson's disease include:
Mitochondrial enhancement: Light at specific wavelengths (typically 600-1000 nm) penetrates tissue and is absorbed by cytochrome c oxidase in mitochondria, enhancing ATP production
Reduced oxidative stress: PBM increases activity of antioxidant enzymes and reduces reactive oxygen species
Anti-inflammatory effects: Modulation of cytokine production and microglial activation
Neuroprotection: Promotion of neurotrophic factor release (BDNF, GDNF) and enhancement of autophagy
Study Design
Allocation: Single-arm (all participants receive active PBM treatment)
Primary Outcome: Change in motor and cognitive function scores
Secondary Outcomes: Safety and tolerability assessments
Eligibility
Diagnosis of Parkinson's disease
Motor and cognitive symptoms requiring intervention
Significance
This trial represents an important non-pharmacological approach to neuroprotection in PD. Unlike drug-based therapies, photobiomodulation offers a non-invasive modality with minimal side effects. The whole-body approach may address both motor and non-motor symptoms simultaneously.
Clinical Evidence for Photobiomodulation in PD
Human Clinical Trials
Multiple small clinical trials have investigated PBM in PD[@pbm2024][@pd2024]:
Motor symptoms: Improvements in UPDRS motor scores (typically 10-20% improvement)
Gait parameters: Enhanced gait velocity and stride length
Sleep quality: Reported improvements in sleep quality
Cognitive function: Mixed results, some studies showing improvement
Mechanism of Action
The therapeutic effects of PBM are mediated through multiple cellular mechanisms[@mitoch2023]:
Mitochondrial Enhancement
Cytochrome c oxidase absorption: Light at 630-670 nm or 810-880 nm is absorbed by cytochrome c oxidase
ATP production: Enhanced mitochondrial electron transport chain activity
Redox state improvement: Increased NAD+/NADH ratio
Anti-inflammatory Effects
Microglial modulation: Shift from pro-inflammatory (M1) to anti-inflammatory (M2) phenotype