TY - JOUR
T1 - Vagal nerve stimulation as a possible non-invasive treatment for chronic widespread pain in Gulf Veterans with Gulf War Illness
AU - Natelson, Benjamin H.
AU - Stegner, Aaron J.
AU - Lange, Gudrun
AU - Khan, Sarah
AU - Blate, Michelle
AU - Sotolongo, Anays
AU - DeLuca, Michelle
AU - Van Doren, William W.
AU - Helmer, Drew A.
N1 - Funding Information:
This project was funded by the Congressionally Directed Medical Research Program # W81XWH-15-1-0615 . Devices and some additional fiscal support were provided by the device manufacturer electroCore Ltd. Additional support came from the War Related Illness and Injury Study Center at VA New Jersey Health Care System's Post-Deployment Health Services (East Orange, NJ) and the Center for Innovations in Quality, Effectiveness and Safety (VA HSRD CIN 13-413) at the Michael E. DeBakey VA Medical Center (Houston, TX).
Funding Information:
This project was funded by the Congressionally Directed Medical Research Program #W81XWH-15-1-0615. Devices and some additional fiscal support were provided by the device manufacturer electroCore Ltd. Additional support came from the War Related Illness and Injury Study Center at VA New Jersey Health Care System's Post-Deployment Health Services (East Orange, NJ) and the Center for Innovations in Quality, Effectiveness and Safety (VA HSRD CIN 13-413) at the Michael E. DeBakey VA Medical Center (Houston, TX).
Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2021/10/1
Y1 - 2021/10/1
N2 - Aims: 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. Main methods: 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. Key findings: 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. Significance: 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.
AB - Aims: 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. Main methods: 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. Key findings: 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. Significance: 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.
KW - Chronic pain
KW - Multisymptom illness
KW - Persian Gulf War
KW - Transcutaneous stimulation
UR - http://www.scopus.com/inward/record.url?scp=85111199612&partnerID=8YFLogxK
U2 - 10.1016/j.lfs.2021.119805
DO - 10.1016/j.lfs.2021.119805
M3 - Article
C2 - 34237313
AN - SCOPUS:85111199612
SN - 0024-3205
VL - 282
JO - Life Sciences
JF - Life Sciences
M1 - 119805
ER -