A new research paper, still awaiting peer review, has been published on NIHR Open Research titled, “Effect of Percutaneous Auricular Nerve Stimulation on Fatigue in Adults with Post-COVID Fatigue (PAuSing-pCF): Results of a Randomised, Sham-Controlled Trial.” Dr Charles Shepherd, MEA Hon. Medical Adviser, provides comment below.
AI Summary
- Researchers tested a non-invasive “vagus nerve stimulation” device to see if it could reduce long COVID fatigue, but after 8 weeks it did not work better than placebo or sham treatments.
- People in all groups reported some improvement over time, suggesting symptoms may naturally fluctuate or improve regardless of the treatment used.
- The treatment appeared safe, but the study concluded that more research is needed to find out whether certain groups of people with long COVID fatigue might still benefit from this type of therapy.
Extracts from the research paper abstract:
Methods
PAuSing-pCF was a single-site, single-blind, randomised, sham-controlled trial in adults with pCF. Participants were assigned to active non-invasive vagus nerve stimulation (taVNS), sham tragus, or active pinna stimulation for 8 weeks, then all crossed over to taVNS for another 8 weeks. The primary outcome was change in Fatigue Visual Analogue Scale (F-VAS) at 8 weeks. Analyses used an intention-to-treat basis, applying regression and mixed-effects models, with additional complier average causal effect (CACE) analyses. Secondary outcomes included patient-reported questionnaires and neurophysiological measures from wearable devices.
Results
Of 114 participants (taVNS n = 39; sham n = 36; placebo n = 39), 90 completed the trial. Fatigue decreased over time across all groups. At 8 weeks, F-VAS change did not differ between taVNS and controls (sham vs taVNS: 2.76, 95% CI −5 to 11, p = 0.50; placebo vs taVNS: 2.05, 95% CI −6 to 10, p = 0.62), with similar results in CACE analyses. In the taVNS group, regression analyses showed associations between fatigue and baseline neurophysiological measures at 16 weeks, but not 8 weeks. Extending taVNS to 16 weeks yielded no further improvement. Among secondary outcomes, only the fatigue impact scale score showed a significant effect at 8 weeks, with higher fatigue in placebo than taVNS.
Conclusions
Non-invasive vagus nerve stimulation did not significantly improve fatigue at 8 weeks compared to sham or placebo. Further research is needed to clarify mechanisms and identify subgroups who may benefit from neuromodulation in pCF.
MEA Comment:
Vagal nerve stimulation is being assessed as a possible form of treatment for both Long Covid and ME/CFS.
While there is patient evidence of benefit from using various commercial devices there is a lack of sound scientific evidence from clinical trials.
The latest clinical trial to report has not found any overall evidence of benefit in relation to fatigue but they did point out that further research may identify a sub group that could benefit.
Dr Charles Shepherd,
Trustee and Hon. Medical Adviser to the ME Association,
Member of the 2018-2021 NICE guideline on ME/CFS committee,
Member of the 2002 Chief Medical Officer's Working Group on ME/CFS
