Study design
coronavirus disease 2019
MAY, CORONAVIRUS DISEASE 2019
This study was a multicenter, prospective, open-label extension to the RESTFUL study, the results of which are published separately [The initiation of this extension study was contingent on obtaining a sufficient supply of TOMAC system components. As a result of global shortages during the coronavirus disease 2019 pandemic, these supplies were not available until December 2021, whereas the RESTFUL study began enrollment in May 2021. Each of the seven clinical centers from the RESTFUL study participated in the extension study with agreement dates ranging from December 2021 to January 2022.All RESTFUL study completers were eligible unless they failed to comply with RESTFUL study requirements; this resulted in ineligibility of 1 potential participant for treatment group (participant changed RLS medication dosage) and 0 participants for control group. Enrollment in the treatment group required direct rollover to continued TOMAC treatment and thus recruited all participants who completed the RESTFUL study after initiation of the extension study at a given site; all participants in the treatment group consented and enrolled on the day of RESTFUL study completion. All participants who completed the RESTFUL study prior to the initiation of the extension study at a given site or who did not consent to the treatment group were eligible for the control group; all control group participants enrolled at 0, 8, 16, or 24 weeks after RESTFUL study completion. Participants who completed the RESTFUL study >24 weeks before the extension study began were excluded from the control group.The treatment group received 24 weeks of active TOMAC treatment (Weeks 1-24) followed by 8 weeks without TOMAC treatment (weeks 24–32) to evaluate response to cessation of TOMAC treatment. Participants taking concurrent RLS medications at study entry were required to maintain a stable dosage and schedule through week 32. The control group received 24 weeks of standard of care with no TOMAC intervention; there were no limitations regarding changes to RLS medication for these participants.The study was conducted in accordance with the International Conference on Harmonization guidelines on good clinical practice and the Declaration of Helsinki, the protocol and informed consent were approved by a central institutional review board (Advarra, Columbia, MD, USA), and all participants provided informed consent. The first participant was enrolled on December 20, 2021, and the trial was registered with 