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

Journal: Life sciences 2021;282():119819

PMID: 34256038

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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.

Address: Institute for Neuro Immune Medicine, Dr. Kiran C. Patel College of Osteopathic Medicine, Nova Southeastern University, Fort Lauderdale, FL, United States; Department of Nutrition, Dr. Kiran C. Patel College of Osteopathic Medicine, Nova Southeastern University, Fort Lauderdale, FL, United States; Halmos College of Natural Sciences and Oceanography, Nova Southeastern University, Fort Lauderdale, FL, United States. Electronic address: [email protected].; RTI International, Research Triangle Park, NC, United States.; Institute for Neuro Immune Medicine, Dr. Kiran C. Patel College of Osteopathic Medicine, Nova Southeastern University, Fort Lauderdale, FL, United States; Miami VA Healthcare System, Miami, FL, United States.; Institute for Neuro Immune Medicine, Dr. Kiran C. Patel College of Osteopathic Medicine, Nova Southeastern University, Fort Lauderdale, FL, United States; Department of Psychology and Neuroscience, Nova Southeastern University, Fort Lauderdale, FL, United States; Department of Computer Science, Nova Southeastern University, Fort Lauderdale, FL, United States.; Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, Houston, TX, United States; Department of Medicine, Baylor College of Medicine, Houston, TX, United States.; War Related Illness & Injury Study Center (WRIISC), VA Palo Alto Health Care System, Palo Alto, CA, United States; Department of Psychiatry & Behavioral Sciences, College of Medicine, Stanford University, Palo Alto, CA, United States.; Department of Environmental Health, Boston University School of Public Health, Boston, MA, United States.

DOI: 10.1016/j.lfs.2021.119819

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MeSH Terms: Aged, Bacopa, Cognitive Dysfunction, Humans, Male, Middle Aged, Persian Gulf Syndrome, Veterans