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@ARTICLE{Herr:281916,
      author       = {Herr, Thorsten and Gamain, Julie and Strauss, S. and
                      Szeska, C. and Flöel, Agnes and Penner, Iris-Katharina and
                      Weymar, Mathias and Grothe, M.},
      title        = {{E}ffect of non-invasive transcutaneous auricular vagus
                      nerve stimulation (ta{VNS}) on non-motor symptoms in
                      multiple sclerosis: study protocol for a randomised,
                      controlled trial.},
      journal      = {BMJ open},
      volume       = {15},
      number       = {11},
      issn         = {2044-6055},
      address      = {London},
      publisher    = {BMJ Publishing Group},
      reportid     = {DZNE-2025-01258},
      pages        = {e103998},
      year         = {2025},
      abstract     = {Research in people with relapsing remitting multiple
                      sclerosis (PwRRMS) is increasingly focusing on non-motor
                      symptoms like cognitive impairment, fatigue and depression.
                      Due to the high negative impact on quality of life and high
                      socioeconomic costs based on these symptoms, more specific
                      research to improve non-motor symptoms is needed.
                      Transcutaneous auricular vagus nerve stimulation (taVNS) has
                      been found to be a cognitive enhancer in preclinical
                      research and was successfully used for the treatment of
                      psychiatric and neurological disorders to combat
                      dysfunctional cognitive and affective processes. However,
                      the capacity of taVNS to improve cognitive and other
                      non-motor symptoms in PwRRMS has not been tested yet. The
                      aim of this study is to evaluate the therapeutic potential
                      of taVNS on cognitive processing speed. Based on ample
                      evidence demonstrating that taVNS promotes adaptive
                      cognitive and affective processes, we hypothesised that
                      taVNS would alleviate cognitive processing speed in
                      PwRRMS.This study protocol describes the prospective,
                      single-centre, SHAM-controlled, single-blinded trial with a
                      planned sample size of 60 participants (30 PwRRMS, with a
                      diagnosis of multiple sclerosis according to McDonald
                      criteria and 30 healthy controls; age: 18-50 years). The
                      Symbol Digit Modalities Test (SDMT) will be used to
                      determine cognitive processing speed, Beck Depression
                      Inventory-II to determine depression and Fatigue Scale for
                      Motor and Cognitive Functions to determine fatigue. The
                      severity of multiple sclerosis will be assessed using the
                      Expanded Disability Status Scale. After baseline assessment,
                      a taVNS protocol (duration: 30 min, tolerance threshold,
                      pulse width: 250 μs, stimulation frequency: 25 Hz, 30 s
                      on/30 s off) will be applied, followed by post-intervention
                      assessment.The study was reviewed and approved by the local
                      ethics committee of the University Medical Centre Greifswald
                      (study reference number: BB137/24).www.drks.de, number:
                      DRKS00034912. Study results will be disseminated through
                      academic conferences as well as peer-reviewed
                      publications.DRKS00034912.},
      keywords     = {Multiple sclerosis (Other) / NEUROPHYSIOLOGY (Other) /
                      Neurophysiology (Other)},
      cin          = {AG Flöel},
      ddc          = {610},
      cid          = {I:(DE-2719)5000081},
      pnm          = {353 - Clinical and Health Care Research (POF4-353)},
      pid          = {G:(DE-HGF)POF4-353},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:41213698},
      pmc          = {pmc:PMC12598993},
      doi          = {10.1136/bmjopen-2025-103998},
      url          = {https://pub.dzne.de/record/281916},
}