Evidence map›Paper›PMID 38898522›Full record

ArticleTrials2024

Transcutaneous auricular vagus nerve stimulation to acutely reduce emotional vulnerability and improve emotional regulation in borderline personality disorder (tVNS-BPD): study protocol for a randomized, single-blind, sham-controlled trial.

Giuseppe Guerriero, Sophie I Liljedahl, Hanne K Carlsen, Marta López Muñoz, Alexander R Daros, Anthony C Ruocco, Steinn Steingrimsson

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05892900 (Transcutaneous Vagus Nerve Stimulation), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT05892900 naunknown statusnot on this map

Transcutaneous Vagus Nerve Stimulation (tVNS) to Acutely Reduce Emotional Vulnerability and Improve Emotional Regulation in Borderline Personality Disorder (tVNS-BPD): a Randomized, Single-blind, Sham-controlled Trial

TypeinterventionalSponsorSahlgrenska University HospitalRan2023 to 2025Enrolled42ConditionsBorderline Personality DisorderArmsTranscutaneous vagus nerve stimulation (tVNS), Sham transcutaneous vagus nerve stimulation (Sham tVNS)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

7 authors.

Giuseppe GuerrieroSection of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden. giuseppe.guerriero@gu.se.ORCID http://orcid.org/0000-0002-3423-8661
Sophie I LiljedahlSection of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.
Hanne K CarlsenSection of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.ORCID http://orcid.org/0000-0003-1656-9624
Marta López MuñozDepartment of Psychiatry for Affective Disorders, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.
Alexander R DarosDepartment of Psychology, University of Windsor, Windsor, Canada.
Anthony C RuoccoDepartment of Psychological Clinical Science, University of Toronto, Toronto, Canada.ORCID http://orcid.org/0000-0002-1942-7181
Steinn SteingrimssonSection of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.

Funding

Sahlgrenska University Hospitals Research Foundations SU-971761
6 · The paper itself

Abstract

backgroundBorderline personality disorder (BPD) is considered a disorder of emotion regulation resulting from the expression of a biologically determined emotional vulnerability (that is, heightened sensitivity to emotion, increased emotional intensity/reactivity, and a slow return to emotional baseline) combined with exposure to invalidating environments. Vagal tone has been associated with activity in cortical regions involved in emotion regulation and a lower resting state of vagal tone has been observed in BPD patients relative to healthy controls. Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) has been shown to reduce temper outbursts in adults with Prader-Willi Syndrome, to enhance recognition of emotions in healthy students, and to improve depressive and anxiety symptoms. Furthermore, a single session of taVNS has been shown to acutely alter the recognition of facial expressions of negative valence in adolescents with MDD and increase emotion recognition in controls. However, the effect of taVNS on emotional vulnerability and regulation in individuals diagnosed with BPD has not been investigated. Our aims are to determine if taVNS is effective in acutely reducing emotional vulnerability and improve emotional regulation in BPD patients.

methodsForty-two patients will be randomized to a single session of taVNS or sham-taVNS while going through an affect induction procedure. It will consist of the presentation of one neutral and three negative affect-evoking 4-min-long videos in sequence, each of which is followed by a 4-min post-induction period during which participants will rate the quality and intensity of their current self-reported emotions (post-induction ratings) and the perceived effectiveness in managing their emotions during the video presentation. The rating of the current self-reported emotions will be repeated after every post-induction period (recovery ratings). Mixed models with individuals as random effect will be used to investigate the ratings at each stage of the study, taking into account the repeated measures of the same individuals at baseline, pre-induction, post-induction, and recovery. DISCUSSION: The study has potential to yield new insights into the role of vagal tone in emotion dysregulation in BPD and offer preliminary data on the effectiveness of taVNS as a possible non-invasive brain stimulation to treat a core symptom of BPD.

trial registrationClinicalTrials.gov NCT05892900. Retrospectively registered on Jun 07, 2023.

Indexed as

Borderline Personality DisorderEmotional RegulationEmotionsRandomized Controlled Trials as TopicTranscutaneous Electric Nerve StimulationVagus Nerve StimulationAdolescentAdultFemaleHumansMaleMiddle AgedSingle-Blind MethodTime FactorsTreatment OutcomeVagus NerveBorderline personality disorderEmotional vulnerabilityEmotion regulationTranscutaneous vagus nerve stimulation

Identifiers

PMID38898522
PMCPMC11186228

What OpenQuestion holds

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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.