Synowiec, Andrea http://orcid.org/0009-0006-4986-4856
Stark-Inbar, Alit http://orcid.org/0000-0001-6434-6447
Weinstein, Maya http://orcid.org/0000-0002-3050-6526
Ironi, Alon http://orcid.org/0000-0002-3992-4978
Mauskop, Alexander http://orcid.org/0000-0002-2861-5184
Funding for this research was provided by:
Theranica
Article History
Received: 13 August 2023
Accepted: 25 September 2023
First Online: 19 October 2023
Declarations
:
: Alit Stark-Inbar and Alon Ironi are employees of and hold stock options in Theranica Bio-Electronics Ltd.; Maya Weinstein and Andrea Synowiec have consulted for Theranica Bio-Electronics Ltd.; Alexander Mauskop has nothing to disclose.
: The study followed the Helsinki Declaration of 1964 and its later amendments. Data was collected from real-world users of the HIPPA-secured Nerivio app<sup>®</sup>. At app signup, patients signed on the terms of using their data, acknowledging that their personal information is provided willingly, and that they agree that their anonymous (deidentified) data may be collected, analyzed, and possibly published for research. Treatments are automatically registered in the Nerivio<sup>®</sup> database (including time of treatment, treatment duration, treatment intensity). At the beginning of each treatment, and again 2 h after that, users can voluntarily answer a few quick questions about their migraine manifestation and therapies they are using. Thus, an additional ethics approval was not required for the analysis of this type of data.