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Research Studies

Part of the mission at the Institute for Neuro-Immune Medicine (INIM) is our collaborative relationship between patient care, clinical & laboratory research and systems biology – all under one roof!

There are numerous reasons why people participate in research. Many individuals, whether they are afflicted with an illness or volunteer as a healthy control, participate in order to help contribute to science and help others. In fact, much of our understanding of various illnesses and even health has been improved because of advances in science and technology with the willingness of individuals, like you, that take part in clinical research. Your role as a volunteer in clinical research is crucial in the pursuit for understanding that will help improve the health of future generations. Without the help of patient or healthy volunteers, clinical research studies could not be accomplished.

Gulf War illness (GWI)

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GWI, or 'chronic multisymptom illness,' affects Gulf War veterans, who were deployed in Operation Desert Storm/Desert Shield. GWI causes chronic symptoms like fatigue, headaches, joint pain, indigestion, insomnia, dizziness, respiratory disorders, and memory problems.


For GWI-related clinical studies details, contact us at 954-262-2870 or GWICTIC@nova.edu.

If you are interested in joining a Gulf War Illness (GWI) trial, please complete the Recruitment Registry form

The Gulf War Illness Clinical Trials and Interventions Center (GWICTIC) is a consortium that includes a dedicated group of investigators, clinical sites, and central cores for administration, data management, and biostatistics2.

Informed by biomarkers, our approach targets multiple mechanisms, addressing chronic oxidative stress and neuroinflammation to reset homeostasis and correct the brain environment.

GWICTIC conducts DoD-funded trials at various institutions, including NSU's Institute for Neuro-Immune Medicine, Boston University, Bronx VAMC, New Jersey WRIISC, and California WRIISC2.

For GWICTIC-related clinical studies details, contact us at 954-262-2870 or GWICTIC@nova.edu.

 

GWICTIC Studies:

Multi-Site/National

This Phase Il study aims to target the immune and neurocognitive defects tied to GWI, likely attributable to chemical and environment exposures in wartime efforts.

Principal Investigator: Amanpreet Cheema, PhD, NSU

For more information, please contact us at 954-262-2870 or email GWICTIC@nova.edu.

Visit ClinicalTrials.gov for study record details.
This open-label dose-comparison study utilizes a combination therapy to assess efficacy in homeostasis reset.

Principal Investigator: Nancy Klimas, MD, NSU & Miami VA Healthcare System

For more information, please contact us at 954-262-2870 or email GWICTIC@nova.edu.

Visit ClinicalTrials.gov for study record details.


Local / south Florida

This open-label dose-comparison study utilizes a combination therapy to assess efficacy in homeostasis reset.

Principal Investigator: Nancy Klimas, MD, NSU & Miami VA Healthcare System

For more information, please contact us at 954-262-2870 or email GWICTIC@nova.edu.

Visit ClinicalTrials.gov for study record details.
In this multi-site trial, we will use a randomized, double-blind, placebo-controlled study design to test whether 300 mg of Nicotinamide Riboside (NR) can achieve the primary objective of increasing plasma NAD+ levels in participants with Gulf War Illness (GWI).

Principal Investigator: Nancy Klimas, MD, NSU & Amanpreet Cheema, PhD, NSU

For more information, please contact us at 954-262-2870 or email GWICTIC@nova.edu.

Visit ClinicalTrials.gov for study record details.

In this study, we aim to reset the underlying mechanisms of disease by suppression of the autoantibody production and inflammatory response using a b-cell suppression therapy (BCST).

Principal Investigator: Nancy Klimas, MD, NSU & Miami VA Healthcare System

For more information, please contact us at 954-262-2870 or email GWICTIC@nova.edu.

Visit ClinicalTrials.gov for study record details.

Summary: The purpose of this study is to confirm the previous positive findings of a dietary treatment using low glutamate diet on the symptoms of Gulf War Illness in a larger group of veterans with Gulf War Illness (GWI).

Principal Investigator: Amanpreet Cheema, PhD, Nova Southeastern University

For more information, please contact us at 954-262-2870 or email GWICTIC@nova.edu.

Visit ClinicalTrials.gov for study record details.


Other Collaborative Studies

Summary: Establish BBRAIN retrospective and prospective biorepository for GWI by data mining from BBRAIN collaborators and recruiting from four prospective resource sites.

Principal Investigator: Kristina Aenlle, PhD, Nova Southeastern University

For more information, please contact us at 954-262-2870 or email GWICTIC@nova.edu.

Summary: This study aims to develop a simple, low-cost diagnostic test, using blood or saliva, to identify Gulf War Illness (GWI) in veterans. The test is designed to track brain injury over time by detecting specific proteins related to the nervous system, potentially leading to better treatment options and disability ratings for veterans.

Principal Investigator: Kristina Aenlle, PhD, Nova Southeastern University

For more information, please contact us at 954-262-2870 or email GWICTIC@nova.edu.

Principal Investigator: Kristina Aenlle, PhD, Nova Southeastern University

For more information, please contact us at 954-262-2870 or email GWICTIC@nova.edu.

Principal Investigator: Kristina Aenlle, PhD, Nova Southeastern University

For more information, please contact us at 954-262-2870 or email GWICTIC@nova.edu.


Completed Studies

Principal Investigator: Nancy Klimas, MD,Miami VA Healthcare System

Visit ClinicalTrials.gov for study record details.

Visit NIH Reporter for study record details.
Visit NIH Reporter for study record details.
Visit ClinicalTrials.gov for study record details.


Funding

We gratefully acknowledge the crucial support from our valued funders, including the Department of Defense (DoD), CDC, Miami VA, NIH, and private entities. Their generous contributions play a vital role in propelling forward our continuous efforts to explore and comprehend complex neuro-inflammatory illnesses. This financial support is crucial for the success of critical clinical trials and interventions, shaping the path toward better understanding and improved treatments.


COVID

covid 19

If you are interested in learning more about the Long COVID research happening at INIM, call 305-275-5450 or email INIMresearch@nova.edu

COVID Studies

The study aims to survey a community-based epidemiologic population in sufficient numbers to estimate the risk of long-term sequelae post-COVID-19 acute infection, with special focus on ME/CFS symptoms. This longitudinal study will involve a large online survey component involving the study populations.

Principal Investigator: Nancy Klimas, MD, NSU & Palacio - VA

This study will conduct a phenotyping assessment to describe the persistent illness that can follow acute COVID19 infection, evaluating clinical presentation and biomarker expression in a subset of the cohort that is also enrolled in a longitudinal study of prevalence, trajectory, and illness severity. This study will involve an on-site clinical assessment to phenotype the ME/CFS-like illness and will draw from an unrecovered symptomatic group, versus a fully recovered comparison group of participants who are currently enrolled in the companion study.

Principal Investigator: Nancy Klimas, MD, NSU & Palacio - VA

The project goal is to inform recruitment and data collection methods and the interpretation of the findings from the COVID UPP Study.

Objectives:

  1. Describe barriers and facilitators to, and motivations for, participating in COVID research studies for people with long COVID conditions to inform the design of the COVID UPP Study.
  2. Describe perceptions of long COVID care and treatment and long COVID research and how it may impact participation into long COVID studies.

Principal Investigator: Nancy Klimas, MD, NSU & Palacio - VA



Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

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ME/CFS is a chronic and severe illness impacting various body systems, causing debilitating fatigue that disrupts daily activities. The cause remains unknown, and symptoms vary among individuals.

Understanding ME/CFS and related fatigue illnesses is limited. Our collaborative research with institutions like CDC, Miami VA, NIH, and private entities aims to improve medical comprehension1. Your participation in research significantly contributes to advancing knowledge and treating ME/CFS. We appreciate your ongoing support.

ME/CFS Studies

This study aimed to use the probiotic Floradapt Intensive GI (other name i3.1), to reduce gastrointestinal (GI) inflammation and normalize the GI, to determine whether resetting your microbiome will help your gut health and perhaps your body as well while simultaneously assessing the effectiveness and safety of this intervention based on the severity of illness.

Visit ClinicalTrials.gov for study record details

Principal Investigator: Nancy Klimas, MD, NSU

Contact: 954-262-2896 kanekastudy@nova.edu

This study is aimed at understanding why some people continue to experience long-term symptoms after recovering from COVID-19, with a focus on changes in gut bacteria and immune response, and whether these symptoms are similar to those of chronic fatigue syndrome.

Principal Investigator: Amanpreet Cheema, PhD, NSU (pilot study)

Safety Measures

Ensuring participant and staff safety is our priority. We monitor operations closely, maintaining regular communication with enrolled participants. Recruitment for studies continues as we strive to advance knowledge and care for complex neuro-inflammatory illnesses.

Thank You

We are very proud of the clinical research studies that we are currently conducting and pleased to collaborate with institutions such as the Centers for Disease Control and Prevention (CDC), Department of Defense (DoD), Veterans Affairs (VA), National Institutes of Health (NIH), Chronic Fatigue Initiative (CFI) along with other universities and private institutions. We are thankful for individuals like you, whose contribution through participation in our studies and donations have allowed us to make advancements in translational medicine. We are happy to answer your questions and provide further information.

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