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Randomized Study of Non-Invasive Autonomic Neuromodulation for Long COVID Published Online in Neuromodulation

ECOR
  • electroCore, Inc. announced the publication of a randomized, open-label controlled study evaluating non-invasive autonomic neuromodulation for Long COVID in the journal Neuromodulation: Technology at the Neural Interface.
  • The four-arm study enrolled 541 participants, with 250 meeting final analytic criteria, comparing cervical transcutaneous vagus nerve stimulation (tcVNS), Sonocea Sonic Augmentation Technology (SAT), a combination of both, and a monitoring-only control over four weeks.
  • Active intervention groups showed improvements across multiple symptom domains including fatigue, breathing, cognition, sleep, mental health, circulation, and daily life impact compared to the monitoring-only group.
  • Depressive symptom scores decreased by approximately 33% for tcVNS, 31% for SAT, and 34% for the combination, compared to 2% in the control group.
  • The combined intervention was associated with a 39% reduction in PTSD-related symptom scores, while the monitoring group saw a 6% increase, though direct comparisons among active groups did not show statistically significant differences.
  • The study was funded by the Defense Threat Reduction Agency of the U.S. Department of Defense, with data collection and management conducted by the independent third party Leidos.
  • Investigators noted limitations including the open-label design, absence of a sham-stimulation control, reliance on patient-reported outcomes, and lack of objective physiological measures, characterizing the findings as hypothesis-generating.
  • Neither electroCore's tcVNS nor Sonocea's SAT has received FDA clearance or approval for treating Long COVID, and their safety and effectiveness for this condition have not been established.
  • The research supports further investigation into autonomic neuromodulation as a potential therapeutic strategy for the multisystem condition of Long COVID, which currently lacks an FDA-approved therapy.
  • The study was conducted remotely in adults with symptoms persisting at least three months following COVID-19 infection.
Company
electroCore, Inc.
Keywords
Nasdaq:ECOR, electroCore, Inc., electroCore, ECOR, tcVNS, vagus nerve, med tech, medical device, gammaCore