Dose-dependent tolerability and safety of transcranial photobiomodulation: a randomized controlled trial
Coelho DRA, Vieira WF, Hurtado Puerto AM, et al.
Lasers in Medical Science · 2025
- Study type
- Randomized trial · secondary safety analysis
- Population
- Adults with major depressive disorder
- Source access
- Abstract & publisher link
A secondary safety analysis of a sham-controlled trial in 31 adults with major depressive disorder, comparing tolerability across different study doses.
What to keep in mind
The analysis did not find statistically significant changes in adverse-event rates, weight or blood pressure. With a small adult sample and brief exposure, absence of a statistically significant difference is not proof of no harm. This is not a pediatric study, and its settings must not be transferred into children’s plans.
Research information is not a prescription. Long-term pediatric transcranial PBM safety is not established by these studies; adult evidence is not a substitute for pediatric evidence. Use only under qualified clinical guidance, with device-specific safety review.
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