Parkinson Disease Clinical Trial
Official title:
Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: A Randomized Controlled Trial (RCT) and an Open Label Extension (OLE) Study
This paired set of studies seeks to establish the safety and efficacy of twice daily time-varying caloric vestibular stimulation (tvCVS) treatments using a solid-state Device developed by Scion NeuroStim, LLC (SNS), also known as ThermoNeuroModulation (TNM™), for treating symptoms associated with PD. The studies will be conducted at 15 centers, at minimum, in the United States and the United Kingdom. Up to 220 participants will first enter the double-blinded, controlled, randomized clinical trial (RCT) and will self-administer tvCVS treatments twice daily in the home setting over a period of 12 weeks (84 days). The RCT will be immediately followed by an open label extension (OLE) study during which all study participants will receive treatment for 12 weeks (84 days). Study participants will be followed for 16 weeks (112 days) post treatment-cessation and then the twice daily treatments will be re-introduced for the final 8 weeks (56 days). The RCT and OLE have been separated into two distinct studies with separate informed consent to enable the closeout and analysis of the RCT portion which will support regulatory submissions during the conduct of the OLE. However, participation in the OLE study will be a selection criterion for participating in the RCT, and thus, the two studies are defined within the context of a single protocol.
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