Faculty Articles
A Randomized Phase II Remote Study to Assess Bacopa for Gulf War Illness Associated Cognitive Dysfunction: Design and Methods of a National Study
Document Type
Article
Publication Title
Life Sciences
ISSN
1879-0631
Publication Date
10-1-2021
Abstract
AIMS: Gulf War Illness (GWI) is a chronic, debilitating, multi-symptom condition affecting as many as one-third of the nearly 700,000 U.S. troops deployed to the Middle East during the 1990-1991 Gulf War (GW). The treatment of GWI relies on symptom management. A common challenge in studying the efficacy of interventions for symptom management is participant recruitment related to factors such as the burden of travelling to study sites and the widespread dispersion of Veterans with GWI. The goal of this study is to assess the efficacy of a novel low-risk therapeutic agent, Bacopa monnieri, for cognitive function in Veterans with GWI and to evaluate the utility of a remote patient-centric study design developed to promote recruitment and minimize participant burden.
MAIN METHODS: To promote effective participant recruitment, we developed a remote patient-centric study design. Participants will be recruited online through social media and through a web-based research volunteer list of GW Veterans. An online assessment platform will be used, and laboratory blood draws will be performed at clinical laboratory sites that are local to participants. Furthermore, the assigned intervention will be mailed to each participant.
SIGNIFICANCE: These study design adaptations will open participation to Veterans nearly nationwide and reduce administrative costs while maintaining methodologic rigor and participant safety in a randomized, placebo-controlled phase II clinical trial.
DOI
10.1016/j.lfs.2021.119819
Volume
282
First Page
119819
Last Page
119819
PubMed ID
34256038
NSUWorks Citation
Cheema, A. K.,
Wiener, L. E.,
McNeil, R.,
Abreu, M. M.,
Craddock, T.,
Fletcher, M. A.,
Helmer, D.,
Ashford, J.,
Sullivan, K.,
Klimas, N. G.
(2021). A Randomized Phase II Remote Study to Assess Bacopa for Gulf War Illness Associated Cognitive Dysfunction: Design and Methods of a National Study. Life Sciences, 282, 119819-119819.
Available at: https://nsuworks.nova.edu/cps_facarticles/1957