Benzinga | Jun 2, 2021 07:33AM EDT

electroCore Announces Publication of Study on Non-Invasive Vagus Nerve Stimulation to Improve Clinical Outcomes and Molecular Biomarkers in Parkinson's Disease Patients

electroCore, Inc. (NASDAQ:ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer-reviewed paper, entitled "Non-Invasive Vagus Nerve Stimulation Improves Clinical and Molecular Biomarkers of Parkinson's Disease in Patients with Freezing of Gait" in the journal NPJ Parkinson's Disease. The paper reports the results of a randomized, double-blind, sham-controlled crossover trial conducted at the Institute of Neurosciences in Kolkata, India in collaboration with the Faculty of Medical Sciences at Newcastle University in England using gammaCore SapphireTM. The study was funded by the Institute of Neurosciences, Kolkata, India.

Neurological disorders are now the leading source of disability in the world, and Parkinson's disease is the fastest-growing of these disorders. As populations age and life expectancy increases, the number of individuals with Parkinson's disease and the duration of the disease will increase, leading to more patients with advanced Parkinson's disease. To address this burden, primary prevention strategies based on the underlying causes of Parkinson's disease and more effective symptomatic treatments are needed.1 There are over 1 million individuals diagnosed with Parkinson's disease in the United States with an estimated total annual economic burden of $51.9 billion.2

The study, which enrolled thirty-six subjects, was undertaken to explore the safety, feasibility and efficacy of self-administered non-invasive vagus nerve stimulation (nVNS) in the treatment of gait and other motor symptoms in Parkinson's disease (PD) patients. In a subgroup of study patients, levels of selected neurotrophins, markers of inflammation and oxidative stress were measured in blood before and after nVNS.

Vagus Nerve Stimulation (VNS) has been found to be beneficial in improving locomotion in a rat model of PD,3 and two independent preliminary studies found improvement in gait in patients with PD after a single application of cervical nVNS.4,5

The study provides preliminary evidence supporting the safety and efficacy of nVNS in treating motor and non-motor symptoms of PD. Patients were satisfied with the treatment and the majority were able to self-administer nVNS. Adverse events were infrequent, non-serious, and similar across both Active and Sham groups. Significant increases in velocity (p=0.003), step length (p=0.007), and a reduction in stance time (p=0.001) were seen in the nVNS treated group compared to shamstimulation, indicating that PD patients were walking not only with a faster pace but also with improved rhythm. Other gait parameters also showed significant improvement from baseline in all five domains, specifically after nVNS treatment, suggesting that nVNS may result in an overall improvement in the quality of gait in PD patients. Treatment with nVNS significantly reduced TNF-? levels (p<0.05) and increased concentrations of reduced glutathione (p<0.05), which are both markers of inflammation in PD patients. Brain Derived Neurotrophic Growth Factors, which are reduced in PD, were significantly increased by nVNS (p<0.05) suggesting a possible disease modifying effect.

Dr. Hrishikesh Kumar, Director of Research and Vice Chairman of the Institute of Neurosciences Kolkata and lead investigator of the study, commented, "We are pleased to have successfully completed the first randomized, double-blind sham-controlled trial to demonstrate the efficacy of cervical nVNS as an adjunctive therapy in PD. Improvements in motor function and gait after one month of treatment with nVNS were significant. Our results clearly support additional work to further understand the potential for nVNS in this indication."

"We congratulate and thank Dr. Kumar, Dr. Baker and the clinical and research teams in Kolkata, India and Newcastle, England, as well as the patients and families that participated in this study," commented Eric Liebler, Senior Vice President of Neurology at electroCore. "Parkinson's disease is the fastest growing neurodegenerative disease in the United States. The impact of PD on patients and their families is devastating and the cost to the healthcare system is staggering. electroCore is looking forward to continuing research to bring nVNS to patients with PD."

The full publication is available at: https://www.nature.com/articles/s41531-021-00190-x