Abstract
INTRODUCTION: Currently, there is no causal cure for Parkinson's disease (PD), and medications and other therapeutic procedures only allow for the reduction of symptoms. Noninvasive neuromodulation is among the potentially promising treatments for PD patients. The present pilot study aimed to evaluate the safety and efficacy of peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM®) in the treatment of PD symptoms with a particular emphasis on disease-related quality of life. METHODS: Twelve patients with clinically established Parkinsońs disease (8 males; mean age 59.5 ± 11.6 years) were enrolled. In addition to state-of-the-art background pharmacotherapy for PD, patients were treated with peroneal eTNM® daily for 30 min for 6 weeks followed by 6 weeks of follow-up without stimulation. The primary endpoint was safety and tolerability, the secondary endpoint was the response of the condition on the 'add-on' peroneal eTNM®. RESULTS: Peroneal eTNM® proved to be feasible for home treatment in the PD population. Treatment-related adverse events were not reported throughout the study. Along with an excellent safety profile, peroneal eTNM® showed considerable positive trends in terms of improvement in quality of life as measured by EQ-5D-5L questionnaire. There was a definitive trend toward a reduction in Section III of the Unified Parkinson's Disease Rating Scale showing positive changes in tremor-related items. At the end of the study, 50 % of the patients were considered clinical responders. CONCLUSIONS: Larger and more rigorously designed studies are needed to validate the utility and position of peroneal eTNM® in the treatment of patients with PD.