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Autoimmune Mechanisms in Fibromyalgia

NCT05815381 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 183

Last updated 2023-04-18

No results posted yet for this study

Summary

A cohort of fibromyalgia (FM) patients (n =90) and healthy controls (HC) (n= 93) was recruited to investigate the associations between human IgG binding to satellite glia cells (SGC) from dorsal root ganglia (DRG) and pathophysiological mechanisms. The study is based on previously identified mechanisms resulting from injecting human IgG antibodies from FM patients, but not HC, in mice (Goebel et al. J Clin Invest. 2021;131(13):e144201). Subjects have been carefully phenotyped using validated questionnaires and quantitative sensory testing (QST) was applied to determine pain sensitivity. A blood sample was taken to quantify anti-SGC IgG, as well as proteins, lipids and metabolites. Skin biopsies were taken to analyze changes in skin innervation (IENFD) and immune cell activation. Magnetic resonance spectroscopy (MRS) and functional magnetic resonance imaging (fMRI) was performed (n=122) to investigate central nervous system pain related mechanisms. Insular glutamate levels, as well as the levels of other brain metabolites will be determined (MRS) and related to symptom severity and anti-SGC IgG levels. Resting state as well as pain related cerebral activation (BOLD) during standardized evoked pain stimuli will be characterized (fMRI) and related to the MRS findings and to anti-SGC IgG levels.

Conditions

  • Fibromyalgia

Interventions

OTHER

Questionnaires, quantitative sensory testing, blood sampling, skin biopsies, functional magnetic resonance imaging, magnetic resonance spectroscopy

se arm/group descriptions

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER

  • The Swedish Rheumatism Ass

    collaborator OTHER

  • Region Stockholm

    collaborator OTHER_GOV

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Eva Kosek, Prof · Karolinska Institutet

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2022-11-22
Completion
2022-11-22

Countries

  • Sweden

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05815381 on ClinicalTrials.gov