Announcing OMF's First ME/CFS Clinical Trial!

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

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Deep Assessment of Neuroinflammation
Using CNS Imaging and Analysis of CSF, Blood, Saliva Samples

Study AIM

To explore the hypothesis that deranged flow of the cerebrospinal fluid (CSF) due to craniocervical obstructions and/or instability may cause deranged intracranial pressure (ICP), neuroinflammation and cardinal symptoms of ME/CFS.

LEAD INVESTIGATORS
  • Jonas Bergquist in collaboration with the Haravard CRC
Updates and Potential
  • Our study will be the first to systematically measure CNS structural abnormalities in a large ME/CFS case-control study using gold-standard methods. It will Highlight CSF pressure, structural abnormalities, and neuroinflammation, with pathophysiological implementations in ME/CFS. Added to this will be collected biospecimens to perform extensive state-of-the art analyses with the ambition to identify diagnostic and prognostic biomarkers

The IRB review will kick off shortly.

STUDY HYPOTHESIS AND DESCRIPTION

The overall aim is to explore the hypothesis that deranged flow of the cerebrospinal fluid (CSF) due to craniocervical obstructions and/or instability may cause deranged intracranial pressure (ICP), neuroinflammation and cardinal symptoms of ME/CFS. If this hypothesis proves true it opens a new research area in ME/CFS and hopes for effective treatment to regulate ICP and relieve symptoms associated with ME/CFS. This study will make use of CNS imaging and analysis of CSF, blood, saliva samples, and will identify proteomic and metabolomic biomarkers of the disease, a highly needed tool in the diagnostic and prognostic process. By the combination of more detailed clinical examination and evaluation and multiOmics biomarker analysis we will be able to provide a more individually adapted care and hopefully cure.

OBJECTIVES

  • Characterize prevalence and severity of CNS structural abnormalities using T1/T2 structural magnetic resonance imaging (MRI).
  • Characterize neuroinflammation by CSF composition analyses and dual MRI/MRS examination.
  • Characterize CSF pressure and flow using invasive and noninvasive techniques.
  • Identify biomarkers of the disease by extensive and detailed analyses of CSF, blood and saliva, using proteomics and metabolomics.

 

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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.
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.
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.”