Evidence map›Paper›PMID 40481908›Full record

ArticleAdvances in therapy2025

Transcutaneous Auricular Vagal Nerve Stimulation for the Treatment of the Fatigue Syndrome in Patients with Primary CNS Lymphoma - A Protocol for a Randomized and Controlled Single Center Clinical Trial.

Mortimer Gierthmuehlen, Sabine Seidel, Niklas Thon, Corinna Seliger

Abstract readClinical Trial Protocol
In one paragraph

Article in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
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

4 authors.

Mortimer GierthmuehlenDepartment of Neurosurgery, University Medical Center Knappschaftskrankenhaus, In der Schornau 23-25, 44892, Bochum, Germany. mortimer.gierthmuehlen@ruhr-uni-bochum.de.ORCID http://orcid.org/0000-0001-8575-6445
Sabine SeidelDepartment of Neurology, University Medical Center Knappschaftskrankenhaus, In der Schornau 23-25, 44892, Bochum, Germany.ORCID http://orcid.org/0000-0002-1671-3297
Niklas ThonDepartment of Neurosurgery, University Medical Center Knappschaftskrankenhaus, In der Schornau 23-25, 44892, Bochum, Germany.ORCID http://orcid.org/0000-0003-0011-5281
Corinna SeligerDepartment of Neurology, University Medical Center Knappschaftskrankenhaus, In der Schornau 23-25, 44892, Bochum, Germany.ORCID http://orcid.org/0000-0002-4923-4495

Funding

Medizinische Fakultät, Ruhr-Universität Bochum F1087-2024
6 · The paper itself

Abstract

introductionCancer-Related Fatigue (CRF) is characterized as a distressing, persistent, and subjective sensation of physical, emotional, and/or cognitive exhaustion that is associated with cancer or its treatment. CRF is commonly observed in patients with cancer and a severely impairing symptom also in patients with the rare primary central nervous lymphoma (PCNSL). While its exact etiology remains unclear, elevated levels of tumor-induced inflammatory cytokines are believed to contribute to its development. Transcutaneous auricular vagal nerve stimulation (taVNS) is a non-invasive method to activate the vagal nerve through electrical stimulation of a vagally innervated area at the tragus. It has shown to modulate the immunsystem, to activate central arousal pathways and to reduce fatigue in autoimmune conditions. In this study, the effect of taVNS on the fatigue syndrome in patients with PCNSL will be investigated.

methodsFor this single-blinded, sham controlled, randomized controlled trial (RCT), 45 adult patients with PCNSL and fatigue in Multidimensional Fatigue Inventory (MFI20)-questionnaire after active treatment will be recruited and randomized to above-threshold-stimulation (A) sub-threshold-stimulation (B) or sham group (C). In Arm A, taVNS is perfomed on the left tragus (25 Hz, pulse width 250 µs,28 s on/32 s off,4 h/day). In Arm B, the patients will be asked to regulate the stimulator below perception threshold. In Arm C, the patients are initially shown how stimulation feels and then asked to decrease the intensity below perception threshold. They then take a non-functional sham-electrode home. Validated questionnaires data (MFI20, Beck Depression Inventory (BDI2), Short-form 26 (SF36), NeuroCogFx and Neurologic Assessment in Neuro-Oncology (NANO) and Hospital Anxiety Depression Scale (HADS)) will be collected at the beginning of the study and after 4 and 8 weeks. PLANNED OUTCOMES: This is the first clinical trial to assess if taVNS improves fatigue symptoms in patients with the primary CNS lymphoma. If taVNS improves fatigue in these patients, it will be a significant gain in quality of life.

trial registrationThe study was approved by the ethics committee (2024-368-f-S) and registered at the DRKS database (DRKS00036323).

Indexed as

Central Nervous System NeoplasmsFatigueLymphomaTranscutaneous Electric Nerve StimulationVagus Nerve StimulationAdultFemaleHumansMaleMiddle AgedQuality of LifeRandomized Controlled Trials as TopicSingle-Blind MethodNeuromodulationPrimary CNS lymphomaTranscutaneousVagus nerve stimulation

Identifiers

PMID40481908
PMCPMC12313758

What Socratic holds

Textmetadata
LicenceCC BY-NC
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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.