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.

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Blood Glucose Self-Monitoring* ; Migraine Disorders*/diagnosis ; Migraine Disorders*/prevention & control; Humans ; Infant, Newborn ; Prospective Studies ; Blood Glucose ; Treatment Outcome ; Randomized Controlled Trials as Topic

Background: The 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.
Methods: Patients 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.
Discussion: To 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 Registration: German Registry of Clinical Studies (Deutsches Register Klinischer Studien) DRKS-ID DRKS00024657. Registered on March 8, 2021.
(© 2022. The Author(s).)

J Biopharm Stat. 2013;23(6):1352-71. (PMID: 24138436)
J Clin Epidemiol. 2006 Apr;59(4):374-80. (PMID: 16549259)
Am J Clin Nutr. 2016 Aug;104(2):288-97. (PMID: 27357094)
Biom J. 2021 Jun;63(5):915-947. (PMID: 33624862)
Lancet Neurol. 2006 Apr;5(4):310-6. (PMID: 16545747)
Cephalalgia. 2008 Sep;28(9):969-79. (PMID: 18624803)
Digit Biomark. 2018 Sep 21;2(3):94-105. (PMID: 32095761)
PLoS One. 2020 Jan 30;15(1):e0228100. (PMID: 31999743)
BMJ. 2013 Jan 08;346:e7586. (PMID: 23303884)
JAMA Netw Open. 2019 Feb 1;2(2):e188102. (PMID: 30735238)
BMJ. 2004 Mar 27;328(7442):744. (PMID: 15023828)
J Headache Pain. 2013 Jan 10;14:1. (PMID: 23566305)
Cephalalgia. 2007 May;27(5):394-402. (PMID: 17403039)
Trials. 2017 May 12;18(1):215. (PMID: 28494802)
Behav Cogn Psychother. 2019 May;47(3):287-302. (PMID: 30185239)
J Headache Pain. 2019 Aug 1;20(1):86. (PMID: 31370788)
J Headache Pain. 2014 Oct 23;15:69. (PMID: 25339342)
Psychother Psychosom. 2016;85(4):218-28. (PMID: 27230863)
NPJ Digit Med. 2020 Feb 17;3:21. (PMID: 32128451)
Psychiatry Res. 2012 Dec 30;200(2-3):83-8. (PMID: 22534500)
Scand J Med Sci Sports. 2018 Mar;28(3):1103-1112. (PMID: 29161767)
J Clin Med. 2022 Feb 20;11(4):. (PMID: 35207390)
Lancet. 2021 Apr 17;397(10283):1505-1518. (PMID: 33773612)
J Affect Disord. 2017 Aug 15;218:15-22. (PMID: 28456072)
J Neurol Neurosurg Psychiatry. 2018 Sep;89(9):970-976. (PMID: 29549193)
JAMA. 2005 May 4;293(17):2118-25. (PMID: 15870415)
Cell. 2015 Nov 19;163(5):1079-1094. (PMID: 26590418)
Nat Med. 2020 Jun;26(6):964-973. (PMID: 32528151)
Schizophr Res. 2000 May 5;42(3):241-7. (PMID: 10785582)
Pain. 2000 Oct;88(1):41-52. (PMID: 11098098)
Semin Neurol. 2018 Apr;38(2):182-190. (PMID: 29791944)
Headache. 2017 Oct;57(9):1399-1408. (PMID: 28842990)
Neurology. 1999 Sep 22;53(5):988-94. (PMID: 10496257)
Cephalalgia. 2020 Sep;40(10):1026-1044. (PMID: 32722936)
Cephalalgia. 2017 Apr;37(5):470-485. (PMID: 27837173)
Cephalalgia. 2021 Mar;41(3):279-293. (PMID: 33472427)
Cell Metab. 2017 Jun 6;25(6):1243-1253.e5. (PMID: 28591632)
NPJ Digit Med. 2018 May 9;1:12. (PMID: 31304297)
Headache. 2018 May;58(5):700-714. (PMID: 29446063)
Int J Sports Med. 2011 Jun;32(6):455-60. (PMID: 21472632)
Lancet Neurol. 2018 Nov;17(11):954-976. (PMID: 30353868)
Agri. 2018 Jan;30(1):8-11. (PMID: 29450870)
Cephalalgia. 2018 Oct;38(12):1805-1816. (PMID: 29333870)

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

0 (Blood Glucose)

Date Created: 20221212 Date Completed: 20221214 Latest Revision: 20221221

20231215

PMC9743661

10.1186/s13063-022-06933-2

36510284