A Double-Blind, Sham Controlled Study of Transcranial Photobiomodulation (PBM) in Parkinsons Disease (P1-11.001)

Objective:

to determine the efficacy and safety of Transcranial Photobiomodulation (PBM) in Parkinsons Disease

Background:

Animal and some pilot human studies suggest that PBM has positive outcomes on the symptoms and signs of Parkinsons Disease. PBM is well tolerated but its overall efficacy is still under investigation. This study commenced in 2021, when Covid-19 meant that many face-to-face interactions were not possible.

Design/Methods:

We conducted a double-blind, randomized, sham controlled trial of PBM vs sham helmet for 12 weeks (20 active, 20 sham) in patients with Parkinsons Disease. This was followed by either a no treatment phase for those on active therapy, or active treatment for those who had been on sham, for a further 12 weeks. The protocol has been previously published. The coprimary endpoints were safety, and efficacy as assessed by the MDS-UPDRS-motor scale. Secondary endpoints were patient reported outcomes.

Results:

The treatment was well tolerated, with no adverse events greater than classified as minor. Of the completers, there was a significant improvement in the UPDRS-motor scale in those who switched to active treatment. The relevance of these results, and the large placebo effect noted in the first 12 weeks, will be discussed. In addition, secondary outcome data will be presented. The issue of performing a clinical trial using video assessments is highlighted.

Conclusions:

PBM is well tolerated. We present the largest sham-controlled blinded study in people living with Parkinsons disease to date. Disclosure: Dr. Liebert has received personal compensation for serving as an employee of Symbyx Pty Ltd. Dr. Liebert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SymByx Pty Ltd. Dr. Liebert has stock in SymByx Pty Ltd. The institution of Dr. Liebert has received research support from Gardos family Trust. Dr. Herkes has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Symbyx. Ms. McGee has nothing to disclose. Dr. Bicknell has received personal compensation for serving as an employee of SymByx Pty Ltd. Dr. Bicknell has stock in SymByx. Pty Ltd. Hosen Kiat has nothing to disclose. Craig McLachlan has nothing to disclose.