Objective: To evaluate the safety and effectiveness of Spectramax™ specialized bandwidth light therapy (LT) as adjunctive treatment in Parkinson’s disease (PD).

Background: Previous studies have suggested that LT improves circadian rhythm and may be effective for both motor and non-motor features of PD. Additionally, pre-clinical studies have suggested that LT may be beneficial in animal models of PD.

Methods: We performed a multi-center, randomized, double-blind, controlled clinical trial of LT in PD patients on stable dopaminergic therapy. Patients with severe dyskinesia, cognitive impairment, high doses of dopaminergic therapy, and prior exposure to LT were excluded. Participants were randomized 1:1 to Spectramax™ LT (950 lux blue/green LED light, λ = 460 – 570 nm) or control LT with a bandwidth that was not thought to be biologically active (100 lux white LED light, λ = 415 – 780 nm), for 60 minutes each evening for 6 months. The primary endpoint was the change from Baseline to the final treatment visit in the MDS-UPDRS Parts 1-3 score. Secondary endpoints included change from Baseline in CGI-I, PDQ-39, PDSS-2, ESS and individual MDS-UPDRS components.

Results: 92 subjects (45 active, 47 sham) were enrolled at 3 centers in the US and Europe. Baseline demographics were comparable in the 2 groups with the exception that the mean age was higher in the active group (70.2 vs. 65.9, p=0.009). The change (SD) from Baseline to 6 months in the MDS-UPDRS 1-3 score was 17.7(2.8) for the active group vs 9.7(3.4) for the control group (LSM difference = 8.0 (4.4); p=0.074). Nominally significant improvements with Spectramax™ light therapy were observed in PDQ-39 (p=0.038) and MDS-UPDRS part I (p=0.006) with a trend for ESS (p=0.054) scores. One subject in each group discontinued due to an adverse event (dizziness in one sham-treated patient and complaints of vision deterioration and light-headedness in one in the active group). The most common adverse events were ocular (dry eye, teary eye, and eye strain) and were more frequent in the active LT group.

Conclusions: Once-daily Spectramax™ LT is associated with a trend in improving PD symptom severity, and improvements of non-motor symptoms and quality of life. LT was well-tolerated. Larger double-blind studies are warranted to further study the effectiveness of LT in PD.

References: 1. Videnovic A, Klerman EB, Wang W, Marconi A, Kuhta T, Zee PC. Timed Light Therapy for Sleep and Daytime Sleepiness Associated With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2017 Apr 1;74(4):411-418. 2. Paus S, Schmitz-Hübsch T, Wüllner U, Vogel A, Klockgether T, Abele M. Bright light therapy in Parkinson’s disease: a pilot study. Mov Disord. 2007 Jul 30;22(10):1495-8. 3. Willis GL, Turner EJ. Primary and secondary features of Parkinson’s disease improve with strategic exposure to bright light: a case series study. Chronobiol Int. 2007;24(3):521-37.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/double-blind-controlled-trial-of-spectramax-light-therapy-for-the-treatment-of-parkinsons-disease-patients-on-stable-dopaminergic-therapy/