Efficacy and safety of tonic motor activation (TOMAC) for medication-refractory restless legs syndrome: a randomized clinical trial.

"DISCLOSURE STATEMENT Financial disclosures: RKB received research support from Noctrix Health, Inc., received grants or contracts for industry funded research from Avadel, BresoTec, Idorsia, Suven, Jazz, Balance, Vanda, Merck, Eisai, Philips, Fresca, Takeda, Liva Nova, Roche, Sommetrics, NLS, Sanofi, Apnimed, received consulting fees from Jazz, Harmony Biosciences, Takeda, Avadel, Oventus, received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Jazz, Eisai, Harmony, Idorsia, owns stock or stock options in WaterMark Medical and Health Humming, LLC. AR received research support from Noctrix Health, Inc., received grants or contracts for clinical trials from Jazz Pharma, Inspire, and Harmony Bio, and received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Jazz Pharma, Inspire, and Harmony Bio. JK received research support from Noctrix Health, Inc. JO received research support from Noctrix Health, Inc. RR received research support from Noctrix Health, Inc. JDH received research support from Noctrix Health, Inc. HSS received research support from Noctrix Health, Inc. JWW received grants or contracts from Merck, the RLS Foundation, and the National Institute on Drug Abuse, is a consultant for Emalex and Disc Medicine, and received support for attending meetings and travel from the International Restless Legs Syndrome Study Group (IRLSSG). JDC is a full-time employee for Noctrix Health, Inc, with associated patents planned, issued, or pending, stock or stock options, and support for attending meetings and/or travel and received grants or funding from the National Institute of Neurological Disorders and Stroke. Financial disclosures: RKB received research support from Noctrix Health, Inc., received grants or contracts for industry funded research from Avadel, BresoTec, Idorsia, Suven, Jazz, Balance, Vanda, Merck, Eisai, Philips, Fresca, Takeda, Liva Nova, Roche, Sommetrics, NLS, Sanofi, Apnimed, received consulting fees from Jazz, Harmony Biosciences, Takeda, Avadel, Oventus, received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Jazz, Eisai, Harmony, Idorsia, owns stock or stock options in WaterMark Medical and Health Humming, LLC. AR received research support from Noctrix Health, Inc., received grants or contracts for clinical trials from Jazz Pharma, Inspire, and Harmony Bio, and received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Jazz Pharma, Inspire, and Harmony Bio. JK received research support from Noctrix Health, Inc. JO received research support from Noctrix Health, Inc. RR received research support from Noctrix Health, Inc. JDH received research support from Noctrix Health, Inc. HSS received research support from Noctrix Health, Inc. JWW received grants or contracts from Merck, the RLS Foundation, and the National Institute on Drug Abuse, is a consultant for Emalex and Disc Medicine, and received support for attending meetings and travel from the International Restless Legs Syndrome Study Group (IRLSSG). JDC is a full-time employee for Noctrix Health, Inc, with associated patents planned, issued, or pending, stock or stock options, and support for attending meetings and/or travel and received grants or funding from the National Institute of Neurological Disorders and Stroke."

"This study was funded by Noctrix Health, Inc., Pleasanton, CA, USA. We thank all involved in the execution of this clinical trial, including the study participants, clinical staff, and Noctrix Health team. We also thank Leavitt Morrison for help with the statistical analysis and Amy Bronstone, PhD, for assistance with manuscript editing. DISCLOSURE STATEMENT: Financial disclosures: RKB received research support from Noctrix Health, Inc., received grants or contracts for industry funded research from Avadel, BresoTec, Idorsia, Suven, Jazz, Balance, Vanda, Merck, Eisai, Philips, Fresca, Takeda, Liva Nova, Roche, Sommetrics, NLS, Sanofi, Apnimed, received consulting fees from Jazz, Harmony Biosciences, Takeda, Avadel, Oventus, received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Jazz, Eisai, Harmony, Idorsia, owns stock or stock options in WaterMark Medical and Health Humming, LLC. AR received research support from Noctrix Health, Inc., received grants or contracts for clinical trials from Jazz Pharma, Inspire, and Harmony Bio, and received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Jazz Pharma, Inspire, and Harmony Bio. JK received research support from Noctrix Health, Inc. JO received research support from Noctrix Health, Inc. RR received research support from Noctrix Health, Inc. JDH received research support from Noctrix Health, Inc. HSS received research support from Noctrix Health, Inc. JWW received grants or contracts from Merck, the RLS Foundation, and the National Institute on Drug Abuse, is a consultant for Emalex and Disc Medicine, and received support for attending meetings and travel from the International Restless Legs Syndrome Study Group (IRLSSG). JDC is a full-time employee for Noctrix Health, Inc, with associated patents planned, issued, or pending, stock or stock options, and support for attending meetings and/or travel and received grants or funding from the National Institute of Neurological Disorders and Stroke."

"The study protocol and informed consent were approved by a central institutional review board (Advarra, Columbia, MD, USA). All participants provided informed consent. The trial was preregistered (ClinicalTrials.gov number, NCT04874155) on May 5, 2021."