Announcing OMF's First ME/CFS Clinical Trial!

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Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME / CFS) Post Treatment Lyme Disease Syndrome (PTLDS), Fibromyalgia Leading Research. Delivering Hope.Open Medicine Foundation® Canada

Driving research of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME / CFS),
Post Treatment Lyme Disease Syndrome (PTLDS), Fibromyalgia and Long COVID.

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Mestinon Clinical Trial

STUDY AIM
The purpose of this clinical trial is to test the exercise response to Mestinon in people with ME/CFS.

Lead

INVESTIGATORS

  • David Systrom, MD

UPDATES

AND POTENTIAL
  • Clinical trial approved (Clinical Trials Number NCT03674541). 
  • Computational analysis has been completed.
  • The results have confirmed the hypothesis of how Mestinon works in ME/CFS patients on one of the pathophysiology of some ME/CFS patients.
  • The manuscript has been published on CHEST.
  • A follow-up analysis of the long-term effect of Mestinon is ongoing, and the study is expected to be completed this year.

STUDY HYPOTHESIS AND DESCRIPTION

Dr. Systrom has consistently found that some people with ME/CFS suffering from fatigue have Preload Failure (PLF). In this instance, PLF is thought to come from an imbalance in the autonomic nervous system and results in reduced filling of the heart during exertion.

Prior studies have shown that treatment with Mestinon results in symptomatic improvement in patients with PLF. Dr. Systrom intends to evaluate the short-term effects of Mestinon on the autonomic nervous system and neurovascular control in people with ME/CFS with PLF. Studying these features will improve our understanding of ME/CFS and this trial may lead to new therapeutic options for some people with ME/CFS.

More details of this trial can be found here.

OBJECTIVES

David M. Systrom, MD, seated in his office.

  1. Select potential candidates for the study.
  2. Enroll subjects and conduct evaluation at Brigham and Women’s Hospital.
  3. Assign subjects in a 1:1 ratio to receive a 60 mg dose of oral pyridostigmine or placebo after an invasive cardiopulmonary exercise test (iCPET). Perform a second iCPET was 50 minutes later.
  4. Conduct biostatistical analysis to assess:
    • the difference in peak exercise oxygen uptake (VO2)
    • exercise pulmonary and systemic hemodynamics and gas exchange.

Consent management

Consent Preferences

Data Subject Access Request (DSAR) Form 

Microvesicles and viral sequencing
Microvesicles are a type of extracellular vesicle that is released from the cell membrane. Vesicles are small, fluid-filled sacs or vacuoles within the body. Sequencing is a technique used to determine the exact sequence of bases (A, C, G, and T) in a DNA (or viral) molecule.
NMR Metabolomics
NMR (Nuclear Magnetic Resonance) is an instrument/tool used to perform metabolic studies, metabolic profiling, and metabolomics in biofluids and tissues for more than 40 years using magnetic fields. There is a very close connection between metabolic measurements and NMR. This connection has flourished because of NMR’s many unique strengths for characterizing complex mixtures’ chemical composition.
Proteomics
The large-scale study of proteins, which are large, complex molecules that are required for structure, function, and regulation of the human body's tissues and organs.
Immune cell profiling
The immune system has many important regulatory roles in disease development and progression. Given the emergence of effective immune therapies, reliable predictors of response are needed. Immune cell profiling determines response by evaluating immune cell populations from treated and untreated samples. For our purposes, we will evaluate the white blood cell response to the viral infection using a process called “Cytof.”
Leukocyte Genomics
A leukocyte is a colorless cell circulating in the blood and body fluids and is involved in counteracting foreign substances and disease. A genome is all genetic material of an organism. Genomics is a biology field focusing on the structure, function, evolution, mapping, and editing of genomes. Therefore, leukocyte genomics is the study of all genetic material of leukocytes.
Metabolomics
Metabolomics is a way to study metabolism – that is, through measuring amounts of the metabolites (small molecules) produced by our bodies as we convert food into energy and other molecules that our cells need to survive. Metabolomics technology is ‘large-scale,’ meaning that several thousand metabolites can be measured from a single sample of e.g., blood or urine.
Micro RNA
Cells use Micro RNA to control whether a particular gene is making too much, too little or the normal amount of its protein at a particular time.
Autoantibodies
Antibodies that react with self-molecules and that occur in healthy individuals and are referred to as natural antibodies or autoantibodies.
Extracellular DNA for viral reactivation and Mitochondrial DNA
exDNA (extracellular DNA), exDNA is often secreted actively and is used to perform several tasks, thereby offering an attractive target or tool for biotechnological, medical, environmental, and general microbiological applications. Viruses are intracellular parasites that rely to a significant extent on the host cell for replication. Viral reactivation occurs when an active replication of the viral genome results in a lytic (degradation of the cell) infection characterized by the release of new progeny (descendant) virus particles.