Evidence map›Paper›PMID 40489633›Full record

Trial reportJMIR human factors2025

Feasibility of a 12-Week, Therapist-Independent, Smartphone-Based Biofeedback Treatment for Episodic Migraine in Adults: Single-Center, Open-Label, 1-Armed Trial.

Amalie Christine Poole, Ingunn Grøntveit Winnberg, Melanie Rae Simpson, Anker Stubberud, Kjersti Grøtta Vetvik, Marte-Helene Bjørk, Lise Rystad Øie, Petter Holmboe, Alexander Olsen, Erling Tronvik and 1 more

Abstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JMIR human factors, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Psychological interventions for migraine.Nature reviews. Neurology · 2026
    Review
  2. Article
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

11 authors.

Amalie Christine PooleNorwegian Centre for Headache Research (NorHead), NTNU Norwegian University of Science and Technology, Trondheim, Norway.ORCID 0009-0007-6747-6475
Ingunn Grøntveit WinnbergDepartment of Neurology and Neurophysiology, St. Olavs University Hospital, Trondheim, Norway, 47 73 59 20 20.ORCID 0000-0001-6383-5257
Melanie Rae SimpsonDepartment of Public Health and Nursing, Faculty of Medicine and Health Sciences, NTNU Norwegian University of Science and Technology, Trondheim, Norway.ORCID 0000-0003-2763-6343
Anker StubberudNorwegian Centre for Headache Research (NorHead), NTNU Norwegian University of Science and Technology, Trondheim, Norway.ORCID 0000-0003-0934-9914
Kjersti Grøtta VetvikNorwegian Centre for Headache Research (NorHead), NTNU Norwegian University of Science and Technology, Trondheim, Norway.ORCID 0000-0002-4286-5147
Marte-Helene BjørkNorwegian Centre for Headache Research (NorHead), NTNU Norwegian University of Science and Technology, Trondheim, Norway.ORCID 0000-0002-5745-1094
Lise Rystad ØieNorwegian Centre for Headache Research (NorHead), NTNU Norwegian University of Science and Technology, Trondheim, Norway.ORCID 0000-0001-9844-4651
Petter HolmboeNordic Brain Tech AS, Oslo, Norway.ORCID 0009-0008-1561-5792
Alexander OlsenNorwegian Centre for Headache Research (NorHead), NTNU Norwegian University of Science and Technology, Trondheim, Norway.ORCID 0000-0001-8691-3860
Erling TronvikNorwegian Centre for Headache Research (NorHead), NTNU Norwegian University of Science and Technology, Trondheim, Norway.ORCID 0000-0001-6059-0151
Tore WergelandNorwegian Centre for Headache Research (NorHead), NTNU Norwegian University of Science and Technology, Trondheim, Norway.ORCID 0000-0003-2295-123X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Biofeedback is an established treatment principle for migraine, but home-based therapy with proven efficacy is not available. Objective: This study aims to assess the feasibility, usability, and safety of 12 weeks of daily use of a novel medical device (Cerebri; Nordic Brain Tech AS) for therapist-independent multimodal biofeedback preventative treatment in adults with episodic migraine. Methods: In this open-label, one-armed trial, 20 adult participants with episodic migraine used Cerebri for 12 weeks. The primary outcome was the feasibility of the Cerebri system, measured by the level of adherence to daily biofeedback and electronic headache diary (eDiary) entries. Secondary outcomes were safety, usability, and efficacy. Results: Initial adherence to biofeedback was high (16/20, 80% in weeks 1-4), declining to 20% (4/20) by weeks 9-12. eDiary adherence remained high (15/20, 75% in weeks 9-12). Reduction in migraine days was not significant (-0.6, 95% CI -2.4 to 1.1 days; P=.47). App usability was impacted by software issues. No safety concerns were reported. Conclusions: Cerebri demonstrates potential in self-managed migraine treatment, with strong initial engagement and high safety. Usability issues, including technical bugs, were identified as the most important modifiable cause for the decline in adherence. This highlights the need for further app refinement to sustain user engagement.

Indexed as

Biofeedback, PsychologyMigraine DisordersMobile ApplicationsSmartphoneAdultFeasibility StudiesFemaleHumansMaleMiddle AgedTreatment Outcomeadherenceappbehavioral therapybiofeedbackcomplementaryfeasibilityheadachemHealthmigrainemobile healthmobile phoneneurologypsychologypsychophysiologysafetytherapist-independentusability

Identifiers

PMID40489633
PMCPMC12169497

What Socratic 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 Socratic graph.