Evidence map›Paper›PMID 36510284›Full record

ArticleTrials2022

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.

Torsten Schröder, Hanna C B Brudermann, Gianna Kühn, Christian Sina, Diamant Thaçi, Matthias Nitschke, Inke R König

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Torsten SchröderInstitute of Nutritional Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck & University of Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.
Hanna C B BrudermannInstitute of Medical Biometry and Statistics, University of Lübeck, University Medical Center Schleswig-Holstein, Campus Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.
Gianna KühnPerfood GmbH, Am Spargelhof 2, Lübeck, Germany.
Christian SinaInstitute of Nutritional Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck & University of Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.
Diamant ThaçiInstitute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.
Matthias NitschkeDepartment of Neurology, University of Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.
Inke R KönigInstitute of Medical Biometry and Statistics, University of Lübeck, University Medical Center Schleswig-Holstein, Campus Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany. inke.koenig@uni-luebeck.de.
University of Lübeck · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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. 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 registrationGerman Registry of Clinical Studies (Deutsches Register Klinischer Studien) DRKS-ID DRKS00024657. Registered on March 8, 2021.

Indexed as

Blood Glucose Self-MonitoringMigraine DisordersBlood GlucoseHumansInfant, NewbornProspective StudiesRandomized Controlled Trials as TopicTreatment OutcomeBlood GlucoseDecentralized studyDigital nutrition programDigital therapeuticDTxMigraine prophylaxisRandomized controlled trialRCTsinCephaleaStudy protocol

Identifiers

PMID36510284
PMCPMC9743661
OpenAlexW4311590064

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.