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The Effects Of Non-Invasive Vagus Nerve Stimulation on Fatigue In Participants With Primary Sjögren's Syndrome

Lookup NU author(s): Dr Jessica Tarn, Emmanuella TraianosORCiD, Amy Collins, Dr Myrto Stylianou, Dr Jehill Parikh, Dr James FrithORCiD, Dr Dennis LendremORCiD, Victoria Macrae, Dr Iain McKinnonORCiD, Dr James Blake, Professor John-Paul TaylorORCiD, Dr Stuart Watson, Dr Peter GallagherORCiD, Professor Andrew BlamireORCiD, Joanne Newton, Professor Fai NgORCiD



This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Objectives: Fatigue is one of the most important symptoms needing improvement in Primary Sjögren's syndrome (PSS). Previous data from our group suggests that non-invasive stimulation of the vagus nerve (nVNS) may improve symptoms of fatigue. This experimental medicine study uses the gammaCore device (electroCore) and a sham device to investigate the effects of nVNS in PSS. Material and Methods: 40 PSS participants were randomly assigned to use active (n = 20) or sham (n = 20) nVNS devices twice daily for 54 days in a double-blinded manner. Patient-reported measures of fatigue were collected at baseline and Day 56: Profile of Fatigue (PRO-F)-Physical, PRO-F-Mental and Visual Analogue Scale of abnormal fatigue (fVAS). Neurocognitive tests, immunological responses, EEG alpha reactivity, muscle acidosis and heart rate variability were compared between devices from baseline to Day 56 using analysis of covariance. Results: PRO-F-Physical, PRO-F-Mental and fVAS scores were significantly reduced at day 56 in the active group only (p=0.02, 0.02, and 0.04 respectively). Muscle bioenergetics and heart rate variability showed no change between arms. There were significant improvements in digit span, a neurocognitive test (p=0.03), and, upon acute nVNS stimulation, frontal region alpha reactivity showed a significant negative relationship with fatigue scores in the active group (p < 0.01). Conclusions: We observed significant improvements in 3 measures of fatigue at day 56 with the active device but not the sham device. Directly following device use, fatigue levels correlate with measures of alpha reactivity suggesting modulation of cholinergic system integrity as a mechanism of action for nVNS.

Publication metadata

Author(s): Tarn J, Evans E, Traianos E, Collins A, Stylianou M, Parikh J, Bai Y, Guan Y, Frith J, Lendrem D, Macrae V, McKinnon I, Simon BS, Blake J, Baker M, Taylor J-P, Watson S, Gallagher P, Blamire A, Newton J, Ng W-F

Publication type: Article

Publication status: Published

Journal: Neuromodulation: Technology at the Neural Interface

Year: 2022

Issue: ePub ahead of Print

Online publication date: 26/10/2022

Acceptance date: 08/08/2022

Date deposited: 01/11/2022

ISSN (print): 1094-7159

ISSN (electronic): 1525-1403

Publisher: Wiley-Blackwell Publishing Ltd.


DOI: 10.1016/j.neurom.2022.08.461


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