Diagnostic Study Results: A Prospective Evaluation of the OPORA App for Assessing Individual Migraine Burden

This study, conducted within the TARA project funded by the European Union’s Horizon Europe programme (Grant Agreement No. 101057524), evaluated the clinical feasibility and functionality of the OPORA mobile application for assessing individual migraine burden using multimodal digital monitoring. In this prospective, open-label cohort study, 35 adult patients with episodic or chronic migraine (mean age 43.8 years; 80% female) were recruited and followed at University Medical Centre Maribor for approximately 10 months. Participants used the OPORA application for daily migraine diary entries and validated questionnaires, alongside continuous monitoring of physiological parameters via a wearable device. A total of 1,134 migraine episodes were recorded. Diary and questionnaire data provided a consistent and reliable assessment of migraine frequency, intensity, and disability, with good agreement between reported migraine days and MIDAS scores. Wearable-derived physiological parameters did not demonstrate robust associations with migraine burden in this exploratory analysis. In contrast, self-reported prodromal symptoms were strongly associated with subsequent attack severity and duration. All data management and statistical analyses were performed by Brai3n, including dataset curation, implementation of quality control procedures, and development of the analytical pipeline to ensure methodological consistency and reliable interpretation of multimodal data. The study confirms the feasibility of multimodal digital migraine monitoring using the OPORA platform and supports the value of patient-reported data for assessing migraine burden. Here, we present and publish the results of this diagnostic study.