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.
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.
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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.
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Who cites it
3 citing papers in PubMed.
- Transcutaneous Auricular Vagal Nerve Stimulation Against Fatigue Syndrome in Patients with Long COVID: Results of the Randomized, Placebo-Controlled Clinical Pilot Trial COVIVA.Neurology and therapy · 2026Article
- taVNS as a potential countermeasure for neurocognitive decline in microgravity.Frontiers in neuroscience · 2025Article
- Cholinergic reflex control of inflammation: mechanistic and translational advances in transcutaneous auricular vagus nerve stimulation across rheumatic, metabolic, and postoperative disorders.Frontiers in immunology · 2025Review
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Authors and funding
4 authors.
Funding
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).
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