Efficacy of the Digital Therapeutic sinCephalea in the prophylaxis of migraine in patients with episodic migraine: study protocol for a digital, randomized, open-label, standard treatment controlled trial

Trials

Study Protocol

Matthias Nitschke¹  Diamant Thaçi²  Hanna C. B. Brudermann³  Inke R. König³  Christian Sina⁴  Torsten Schröder⁵  Gianna Kühn⁶ 

[1] Department of Neurology, University of Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany;Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany;Institute of Medical Biometry and Statistics, University of Lübeck, University Medical Center Schleswig-Holstein, Campus Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany;Institute of Nutritional Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck & University of Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany;Medical Department 1, Section of Nutritional Medicine University Hospital of Schleswig-Holstein, Campus Lübeck & University of Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany;Institute of Nutritional Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck & University of Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany;Perfood GmbH, Am Spargelhof 2, Lübeck, Germany;Perfood GmbH, Am Spargelhof 2, Lübeck, Germany;

关键词: Digital therapeutic;    DTx;    Migraine prophylaxis;    sinCephalea;    Digital nutrition program;    RCT;    Randomized controlled trial;    Study protocol;    Decentralized study;   

DOI  :  10.1186/s13063-022-06933-2

 received in 2022-03-03, accepted in 2022-11-15,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundThe German government implemented the Digital Healthcare Act in order to bring Digital Therapeutics into standard medical care. This is one of the first regulatory pathways to reimbursement for Digital Therapeutics (DTx). The Digital Therapeutic sinCephalea is intended to act as a prophylactic treatment of migraine by reducing the migraine days. For this, sinCephalea determines personalized nutritional recommendations using continuous glucose monitoring (CGM) data and enables the patients to follow a personalized low-glycemic nutrition. Migraine is a headache disorder with the highest socioeconomic burden. Emerging evidence shows that CGM-based personalized nutritional recommendations are of prophylactic use in episodic migraine. However, prospective data are yet missing to demonstrate clinical effectiveness. This study is designed to fill this gap.MethodsPatients between 18 and 65 years of age with proven migraine and a minimal disease severity of 3 migraine days per month are included. After a 4-week baseline phase as a pre-study, patients are randomized to the DTx intervention or a waiting-list control. The objective of the study is to show differences between the intervention and control groups regarding the change of migraine symptoms and of effects of migraine on daily life.DiscussionTo our knowledge, this is the first systematic clinical trial with a fully digital program to enable patients with migraine to follow a personalized low-glycemic nutrition in order to reduce their number of migraine days and the migraine-induced impact on daily life. Designing a clinical study using a digital intervention includes some obstacles, which are addressed in this study approach.Trial registrationGerman Registry of Clinical Studies (Deutsches Register Klinischer Studien) DRKS-ID DRKS00024657. Registered on March 8, 2021.

【 授权许可】

CC BY   
© The Author(s) 2022

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