ArticleF1000Research2024
Biofeedback therapy using Cerebri for the prevention of migraine attacks in adults with episodic migraine (BioCer): a randomized, wait-list controlled trial - the study protocol.
Article in F1000Research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05616741 (A Randomized, Wait-list Controlled Trial of Daily, Home-based Biofeedback Therapy Using Cerebri for the Prevention of Migraine Attacks in Adults With Episodic Migraine), which is not on this map. Cited by 2 papers.
What it found
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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.
A Randomized, Wait-list Controlled Trial of Daily, Home-based Biofeedback Therapy Using Cerebri for the Prevention of Migraine Attacks in Adults With Episodic Migraine
Who cites it
2 citing papers in PubMed.
- Forecasting migraine with time-series machine learning from mobile health data.The journal of headache and pain · 2026Article
- The impact of biofeedback in enhancing chronic pain rehabilitation: A systematic review of mechanisms and outcomes.Heliyon · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: Biofeedback is a non-pharmacological treatment option valued for its minimal risk of adverse events and offers a safe alternative for individuals seeking preventive care for migraine. Despite level A evidence for migraine prevention, biofeedback treatment is still unavailable to most patients. We developed a novel medical device (Cerebri) for multimodal biofeedback treatment that omits the need for healthcare personnel involvement. Cerebri consists of a smartphone application (app) and two wireless sensors. Unique in its approach, the Cerebri app seamlessly integrates three biofeedback modalities - heart rate variability, temperature, and electromyography - making it a comprehensive, therapist-independent solution for non-pharmacological migraine management. Methods: Biofeedback therapy using Cerebri for the prevention of migraine attacks in adults with episodic migraine (The BioCer study) is an open-label, randomized, waitlist-controlled, multicenter trial. This study investigates the safety and efficacy of daily home-based biofeedback sessions using the Cerebri device. A total of 286 participants will be randomized to either a 12-week intervention arm or waitlist control arm. The primary outcome is the change in the mean number of migraine days from baseline to the last 28-day period during the treatment phase in the treatment group compared with the control group. The primary outcome variable is prospectively collected through daily eDiary entries. A limitation is the inability to conduct a sham-controlled trial of biofeedback. Ethics and Dissemination: Approval from the ethics committee and competent authorities was obtained prior to study initiation. Participation is voluntary and informed and written consent is obtained prior to inclusion. The results of this trial will be published in peer-reviewed international medical journals and communicated to patients and healthcare personnel through the relevant channels. Trial registration numbers: EUDAMED: CIV-NO-22-08-040446REK (Regional Committees for Medical and Health Research Ethics): 502734 Date of approval 2022-10-14Trial registration: NCT05616741, 2022-11-15, https://clinicaltrials.gov/study/NCT05616741.
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Registered trials
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.