Author: Benjamin H Natelson1, Aaron J Stegner2, Gudrun Lange1, Sarah Khan1, Michelle Blate1, Anays Sotolongo3, Michelle DeLuca3, William W van Doren3, Drew A Helmer4
1 Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
2 Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: email@example.com.
3 War Related Illness and Injury Study Center, VA New Jersey Health Care System, East Orange, NJ, USA.
4 Michael E. DeBakey VA Medical Center, Houston, TX, USA.
Conference/Journal: Life Sci
Date published: 2021 Jul 5
Other: Special Notes: doi: 10.1016/j.lfs.2021.119805. , Word Count: 259
Widespread pain and headache are common in Gulf War Illness with suboptimal treatments available. We tested the efficacy of non-invasive, transcutaneous vagal nerve stimulation (nVNS) for relief of widespread pain and migraine in Gulf War Veterans with GWI.
A 10-week double-blind, randomized controlled trial of nVNS used the gammaCore (ElectroCore, Inc.) compared to sham stimulation with the same device followed by a 10-week open-label follow up with active nVNS. The primary outcome was a numerical pain rating at the end of the blinded period. Secondary outcomes included physical function, migraine frequency and severity, and impression of change during the blinded and open-label periods. Two-factor MANOVA models tested for significant differences between groups from baseline to end of the blinded period and during the open-label period.
Among 27 participants enrolled and issued a nVNS device, there was a slight improvement in pain ratings from baseline to the end of the blinded phase [6.18 (±0.82) vs. 5.05 (±2.3); p = 0.040] which did not differ between active and sham nVNS. Physical function was also slightly improved overall without group differences. There were no significant changes in migraine frequency or severity during the blinded period. Twenty participants started in the open-label phase; no statistically significant changes in pain, physical function, migraine measures, or impression of change were noted during this phase.
Veterans with GWI actively treated with nVNS reported no improvement in either widespread pain or migraine frequency or severity relative to Veterans with GWI who received sham nVNS.
Keywords: Chronic pain; Multisymptom illness; Persian Gulf War; Transcutaneous stimulation.
PMID: 34237313 DOI: 10.1016/j.lfs.2021.119805