In this post hoc analysis of attack frequency over time and expanded response rates, the practical combination of nVNS and currently available cCH treatments led to rapid, sustained, and clinically meaningful responses. Within 2 weeks after the addition of prophylactic nVNS to SoC, sustained reductions in attack frequency were significantly greater with this combination than with SoC alone. After 4 weeks, patients’ average weekly attack frequency was 41% lower with prophylactic nVNS + SoC treatment than with SoC alone. The rapid decrease in weekly attack frequency justifies a 4-week trial period to identify responders to nVNS, with a high degree of confidence, among patients with cCH. The ≥25%, ≥50%, and ≥75% response rates were significantly higher with adjunctive nVNS than with SoC alone.
Preva study group
Investigators are listed by country. 1. Germany: Migraine and Headache Clinic, Königstein – Charly Gaul, MD, PhD (principal investigator), and Ronald Brand, MD (subinvestigator); University Hospital-Essen, Essen – Hans-Christoph Diener, MD, PhD (principal investigator), and Kasja Rabe, Holle Dagny, Steffen Nägel, MD, and Maja Bak, MD (subinvestigators); Ludwig-Maximilian University, Munich – Andreas Straube, MD (principal investigator), and Bernhard Blum, MD, Ruth Ruscheweyh, MD, and Ozan Eren, MD (subinvestigators); Department of Neurology, Charité University Hospital, Berlin – Uwe Reuter, MD (principal investigator), and Heike Israel-Willner, MD, and Lars Neeb, MD (subinvestigators); Krankenhaus Lindenbrunn, Lindenbrunn – Stefan Evers, MD, PhD (principal investigator); 2. United Kingdom: The Walton Centre for Neurology and Neurosurgery, Liverpool – Nicholas Silver, MBBS, PhD (principal investigator), and Helen Banks, MD, and Heike Arndt, MD (subinvestigators); The Southern General Hospital, Glasgow – Alok Tyagi, MD (principal investigator); Hull Royal Infirmary, Hull – Fayyaz Ahmed, MD (principal investigator), and Anwar Osman, MD (subinvestigator); 3. Belgium: Liège University, Liège – Delphine Magis, MD, PhD (principal investigator), and Jean Schoenen, MD (subinvestigator); 4. Italy: Sant’Andrea Hospital, Sapienza University of Rome, Rome – Paolo Martelleti, MD (principal investigator), and Andrea Negro, MD (subinvestigator).