A Randomized Placebo-Controlled Study of a Transcranial Photobiomodulation Helmet in Parkinson’s Disease: Post-Hoc Analysis of Motor Outcomes

Abstract

Emerging evidence is increasingly supporting the use of transcranial photobiomodulation (tPBM) to improve symptoms of neurodegenerative diseases, including Parkinson’s disease (PD). The objective of this study was to analyse the safety and efficacy of tPBM for PD motor symptoms. The study was a triple blind, randomized placebo-controlled trial with 40 idiopathic PD patients receiving either active tPBM (635 nm plus 810 nm LEDs) or sham tPBM for 24 min per day (56.88J), six days per week, for 12 weeks. The primary outcome measures were treatment safety and a 37-item MDS-UPDRS-III (motor domain) assessed at baseline and 12 weeks. Individual MDS-UPDRS-III items were clustered into sub-score domains (facial, upper-limb, lower-limb, gait, and tremor). The treatment produced no safety concerns or adverse events, apart from occasional temporary and minor dizziness. There was no significant difference in total MDS-UPDRS-III scores between groups, presumably due to the placebo effect. Additional analyses demonstrated that facial and lower-limb sub-scores significantly improved with active treatment, while gait and lower-limb sub-scores significantly improved with sham treatment. Approximately 70% of participants responded to active treatment (≥5 decrease in MDS-UPDRS-III score) and improved in all sub-scores, while sham responders improved in lower-limb sub-scores only. tPBM appears to be a safe treatment and improved several PD motor symptoms in patients that responded to treatment. tPBM is proving to be increasingly attractive as a possible non-pharmaceutical adjunct therapy.

Transcranial photobiomodulation for brain diseases: review of animal and human studies including mechanisms and emerging trends

“…96,226 In clinical trials, McGee et al found that tPBM (635 nm plus 810 nm LEDs) could safely and meaningfully improve individual motor signs of PD. 33 Hamilton et al developed a helmet device with several LEDs with wavelengths of 670, 810, and 850 nm and reported improvement in PD progression. 31 In fact, owing to the exponential attenuation of light traveling through skull and brain tissues, only a very limited number of neurons can absorb sufficient photons for positive effects.…”

“…In clinical trials, McGee et al. found that tPBM (635 nm plus 810 nm LEDs) could safely and meaningfully improve individual motor signs of PD 33 . Hamilton et al.…”

“…found that tPBM (635 nm plus 810 nm LEDs) could safely and meaningfully improve individual motor signs of PD. 33 Hamilton et al. developed a helmet device with several LEDs with wavelengths of 670, 810, and 850 nm and reported improvement in PD progression.…”

“…Notes: the data are summarized from Refs. 20–23 and 51–70, (ischemic stroke), 71–73 (HI), 74 (intracerebral hemorrhage), 25–28, 75–83 (AD), 29–34, 84–96 (PD), 97–99 (multiple sclerosis), 35–40, 100–116 (TBI), 117 (possible chronic traumatic encephalopathy), 41–44, 118–126 (depression), 45–50, 127...…”

“… 19 During the past two decades, a tremendous number of pre-clinical experiments with animals and clinical trials with humans have demonstrated beneficial effects. Clinical trials with humans include, in particular, the treatment of ischemic stroke, 20 – 24 Alzheimer’s disease (AD), 25 – 28 Parkinson’s disease (PD), 29 – 34 traumatic brain injury (TBI), 35 – 40 depression, 41 – 44 aging, 45 – 50 etc. In these studies, the parameters of the light used are extremely sophisticated and deserve to be deliberated.…”