Evidence map›Paper›PMID 34729551›Full record

ArticleIBRO neuroscience reports2021

EEG revealed improved vigilance regulation after stress exposure under Nx4 - A randomized, placebo-controlled, double-blind, cross-over trial.

Tara Chand, Sarah Alizadeh, Hamidreza Jamalabadi, Luisa Herrmann, Marina Krylova, Galina Surova, Johan van der Meer, Gred Wagner, Veronika Engert, Martin Walter

Erratum issued Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in IBRO neuroscience reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02602275 (Neuronal Correlates of Neurexan® Action in Mildly to Moderately Stressed Probands - A Randomized, Placebo-controlled, Double-blind, Cross-over Trial of Mode of Action and Response Prediction by Functional Magnetic Resonance Imaging MRI), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.9field-weighted citation impact, top 13% 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.

NCT02602275 phase2completednot on this map

Neuronal Correlates of Neurexan® Action in Mildly to Moderately Stressed Probands - A Randomized, Placebo-controlled, Double-blind, Cross-over Trial of Mode of Action and Response Prediction by Functional Magnetic Resonance Imaging MRI

TypeinterventionalSponsorBiologische Heilmittel Heel GmbHRan2015 to 2015Enrolled53ConditionsAcute Stress ReactionArmsNeurexan, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 3 countries.

Tara ChandDepartment of Psychiatry and Psychotherapy, Jena University Hospital, Jena 07743, Germany.
Sarah AlizadehDepartment of Psychiatry and Psychotherapy, Jena University Hospital, Jena 07743, Germany.
Hamidreza JamalabadiDepartment of Psychiatry and Psychotherapy, University of Tübingen, Tübingen 72076, Germany.
Luisa HerrmannDepartment of Psychiatry and Psychotherapy, Jena University Hospital, Jena 07743, Germany.
Marina KrylovaDepartment of Psychiatry and Psychotherapy, Jena University Hospital, Jena 07743, Germany.
Galina SurovaDepartment of Psychiatry and Psychotherapy, Leipzig University Medical Center, Leipzig 04103, Germany.
Johan van der MeerQIMR Berghofer Medical Research Institute, Brisbane 4006, Australia.
Gred WagnerDepartment of Psychiatry and Psychotherapy, Jena University Hospital, Jena 07743, Germany.
Veronika EngertInstitute of Psychosocial Medicine, Psychotherapy and Psychooncology, Jena University Hospital, Jena 07443, Germany.
Martin WalterDepartment of Psychiatry and Psychotherapy, Jena University Hospital, Jena 07743, Germany.
Jena University Hospital · DEUniversity of Tübingen · DEAmsterdam University Medical Centers · NLLeipzig University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesVigilance is characterized by alertness and sustained attention. The hyper-vigilance states are indicators of stress experience in the resting brain. Neurexan (Nx4) has been shown to modulate the neuroendocrine stress response. Here, we hypothesized that the intake of Nx4 would alter brain vigilance states at rest.

methodIn this post-hoc analysis of the NEURIM study, EEG recordings of three, 12 min resting-state conditions in 39 healthy male volunteers were examined in a randomized, placebo-controlled, double-blind, cross-over clinical trial. EEG was recorded at three resting-state sessions: at baseline (RS0), after single-dose treatment with Nx4 or placebo (RS1), and subsequently after a psychosocial stress task (RS2). During each resting-state session, each 2-s segment of the consecutive EEG epochs was classified into one of seven different brain states along a wake-sleep continuum using the VIGALL 2.1 algorithm.

resultsIn the post-stress resting-state, subjects exhibited a hyper-stable vigilance regulation characterized by an increase in the mean vigilance level and by more rigidity in the higher vigilance states for a longer period of time. Importantly, Nx4-treated participants exhibited significantly lower mean vigilance level compared to placebo-treated ones. Also, Nx4- compared to placebo-treated participants spent comparably less time in higher vigilance states and more time in lower vigilance states in the post-stress resting-state.

conclusionStudy participants showed a significantly lower mean vigilance level in the post-stress resting-state condition and tended to stay longer in lower vigilance states after treatment with Nx4. These findings support the known stress attenuation effect of Nx4.

Indexed as

EEGNeurexanPsychosocial stressResting-stateVigilance

Identifiers

PMID34729551
PMCPMC8545679
OpenAlexW3201956722

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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.