A Randomized Phase II Remote Study to Assess Bacopa for Gulf War Illness Associated Cognitive Dysfunction: Design and Methods of a National Study

Amanpreet K Cheema; Laura E Wiener; Rebecca B McNeil; Maria M Abreu; Travis Craddock; Mary A Fletcher; Drew A Helmer; J Wesson Ashford; Kimberly Sullivan; Nancy G Klimas

doi:10.1016/j.lfs.2021.119819

A Randomized Phase II Remote Study to Assess Bacopa for Gulf War Illness Associated Cognitive Dysfunction: Design and Methods of a National Study

Amanpreet K Cheema
, Laura E Wiener
, Rebecca B McNeil
, Maria M Abreu
, Travis Craddock
, Mary A Fletcher
, Drew A Helmer
, J Wesson Ashford
, Kimberly Sullivan
, Nancy G Klimas

College of Psychology

Research output: Contribution to journal › Article › peer-review

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.

Original language	American English
Pages (from-to)	119819
Journal	Life Sciences
Volume	282
DOIs	https://doi.org/10.1016/j.lfs.2021.119819
State	Published - Oct 1 2021

Bibliographical note

Funding

To address these recruitment challenges, our research team developed a novel remote patient-centric intervention study design for Veterans with GWI. This study is supported by the multi-investigator, multi-site Gulf War Illness Clinical Trials and Interventions Consortium (GWICTIC) funded by the Congressionally Directed Medical Research Programs (CDMRP). The goal of the GWICTIC is to focus on phase I and phase II clinical trials in a collaborative research network that engages many of the clinical and preclinical experts in the field in partnership with an advocacy coalition. The members of the Veterans’ Advocacy Committee advise the investigators on the challenges faced by the Veterans and provide invaluable input for the study design and implementation.This research was funded by the United States Department of Defense Congressionally Directed Medical Research Programs (CDMRP) awards (http://cdmrp.army.mil/) [grant number W81XWH1820062] and in part by the Houston VA Health Services Research & Development Center for Innovations [grant number CIN13-413]. The opinions and assertions contained herein are the private views of the authors and do not reflect the views of the United States Department of Defense or the United States Department of Veterans Affairs. The authors acknowledge our Veterans’ Advocacy Committee members Jimmy Arocho, Marylyn Harris, Denise Nichols, Marshall Harvey, and T. Anthony Langeland for providing valuable input which shaped the design of this study. We also acknowledge Elizabeth Balbin, Sara Moeinian and Zena Kirby for collaborative outreach efforts and Beth Gilbert and Stephanie Zimmer for formal review. To address these recruitment challenges, our research team developed a novel remote patient-centric intervention study design for Veterans with GWI. This study is supported by the multi-investigator, multi-site Gulf War Illness Clinical Trials and Interventions Consortium (GWICTIC) funded by the Congressionally Directed Medical Research Programs (CDMRP). The goal of the GWICTIC is to focus on phase I and phase II clinical trials in a collaborative research network that engages many of the clinical and preclinical experts in the field in partnership with an advocacy coalition. The members of the Veterans’ Advocacy Committee advise the investigators on the challenges faced by the Veterans and provide invaluable input for the study design and implementation. This research was funded by the United States Department of Defense Congressionally Directed Medical Research Programs (CDMRP) awards ( http://cdmrp.army.mil/ ) [grant number W81XWH1820062] and in part by the Houston VA Health Services Research & Development Center for Innovations [grant number CIN13-413]. The opinions and assertions contained herein are the private views of the authors and do not reflect the views of the United States Department of Defense or the United States Department of Veterans Affairs.

Funders	Funder number
VA Health Services Research & Development Center for Innovations	CIN13-413
U.S. Department of Defense
Congressionally Directed Medical Research Programs	W81XWH1820062
Department of Veterans Affairs

ASJC Scopus Subject Areas

General Pharmacology, Toxicology and Pharmaceutics
General Biochemistry,Genetics and Molecular Biology

Keywords

Bacopa
Persian Gulf Syndrome
aged
cognitive dysfunction
humans
male
middle aged
veterans
Gulf War Illness
Veterans health
Gulf War
Clinical trial
Military health

Disciplines

Psychology

Access to Document

10.1016/j.lfs.2021.119819

https://doi.org/10.1016/j.lfs.2021.119819

Cite this

Cheema, A. K., Wiener, L. E., McNeil, R. B., Abreu, M. M., Craddock, T., Fletcher, M. A., Helmer, D. A., Ashford, J. W., 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. https://doi.org/10.1016/j.lfs.2021.119819

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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.",

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AU - Fletcher, Mary A

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A Randomized Phase II Remote Study to Assess Bacopa for Gulf War Illness Associated Cognitive Dysfunction: Design and Methods of a National Study

Abstract

Bibliographical note

Funding

ASJC Scopus Subject Areas

Keywords

Disciplines

Access to Document

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