Protocol for randomized controlled trial to evaluate the safety and feasibility of a novel helmet to deliver transcranial light emitting diodes photobiomodulation therapy to patients with Parkinson’s disease

Abstract

IntroductionParkinson’s disease (PD) is the second most common, progressive, and debilitating neurodegenerative disease associated with aging and the most common movement disorder. Photobiomodulation (PBM), the use of non-thermal light for therapeutic purposes using laser or light emitting diodes (LED) is an emerging non-invasive treatment for a diverse range of neurological conditions. The main objectives of this clinical trial are to investigate the feasibility, safety, tolerability, and efficacy of a novel transcranial LED helmet device (the “PDNeuro”) in the alleviation of symptoms of PD.Methods and analysisThis is a 24-week, two-arm, triple-blinded randomized placebo-controlled clinical trial of a novel transcranial “PDNeuro” LED Helmet, comparing an active helmet to a sham helmet device. In a survey, 40 PD participants with Hoehn and Yahr Stage I–III during ON periods will be enrolled and randomly assigned into two groups. Both groups will be monitored weekly for the safety and tolerability of the “PDNeuro” LED Helmet. Clinical signs and symptoms assessed will include mobility, fine motor skills and cognition, with data collected at baseline, 12 weeks, and 24 weeks. Assessment tools include the TUG, UPDRS, and MoCA all validated for use in PD patients. Patient’s adherence to the device usage and participant drop out will be monitored weekly. At 12 weeks both placebo and treatment groups will crossover and placebo participants offered the treatment. The main indicator for clinical efficacy of the “PDneuro” Helmet is evidence of sustained improvements in motor and non-motor symptoms obtained from participant self-reported changes, carer reporting of changes and objective reassessment by the investigators. The outcomes will assist in a future larger randomized trial design.Clinical Trial Registration[https://www.anzctr.org.au], identifier [12621001722886].

Use of either transcranial or whole‐body photobiomodulation treatments improves COVID‐19 brain fog

“…Repeated neurophysiological testing (6 tests over 4 weeks) with MoCA, DSST, and trail-making tests could conceivably improve performance as a result of gaining familiarity with the test and practice; however, no papers have been published for a learning effect on these tests. Such an effect is less likely with qEEG parameters, as there is no evidence that processing speeds or power can be influenced by repeated practice, and placebo effects are less likely to persist over a full course of treatment [74,111]. In addition, further examination of current data is planned to determine if biomarkers provided by qEEG can be used to predict, early in the clinical treatment course, which patients would most likely benefit from PBM treatment.…”

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

“…Each participant was re-assessed by the same assessor. The protocol used in this study has been described previously [19]. Briefly, the study was a triple-blind [20], randomized placebo-controlled trial (RCT), conducted over 24 weeks entirely remotely, with online, rather than in person face-to-face contact with trial participants.…”

“…The sham device was identical but delivered no therapeutic light. The sham group was told that light was infrared and could not be seen [19]. The tPBM protocol consisted of 12 weeks of 24-min sessions, six times per week.…”

Remote photobiomodulation targeted at the abdomen or legs provides effective neuroprotection against parkinsonian MPTP insult

“…Other investigators have observed similar neuroprotective effects in PD models using other species, such as rats (Oueslati et al, 2015) and flies (Vos et al, 2013), as reviewed elsewhere (Johnstone et al, 2021; Petrucco et al, 2020). In addition, clinical trials assessing the safety profile of transcranial or multi‐site PBM have established that, when applied within the correct dose window, the treatment is safe and not associated with an increase in adverse events (Blivet et al, 2022; Cassano et al, 2022; McGee et al, 2022). Histological observations in non‐human primates receiving intracranial PBM provide further evidence that PBM has an acceptable safety profile (Darlot et al, 2016; Moro et al, 2017).…”