This study focuses on individuals who have Parkinson's disease (PD) and are fully vaccinated from COVID-19 (coronavirus). The purpose of the study is to evaluate the safety and effectiveness of an investigational neuromodulation device for the treatment of non-motor symptoms in people with PD. Researchers aim to determine whether the non-invasive neuromodulation treatment effectively improves non-motor symptoms and/or improves overall quality of life in these patients. A non-invasive device stays outside of the body (is not implanted and does not penetrate the skin). Neuromodulation means that the device stimulates activity in the brain. The device consists of a headset and a base station that powers the headset. When activated, it will deliver a prescribed stimulation pattern for approximately 20 minutes. Participants will be randomly assigned to 1 of 2 treatment groups. Each group will use the same study device but will receive a different treatment mode (neurostimulation pattern). Participants will also be asked to complete multiple assessments and questionnaires.
Non-Invasive Brainstem Modulation for the Management of Non-motor symptoms in Parkinson's Disease: A Randomized Controlled Trial and an Open Label Extension Study