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The Effect of Autoreactive Autoantibodies on Peripheral and Central Disease Mechanisms in Fibromyalgia.

NCT07346950 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 164

Last updated 2026-01-16

No results posted yet for this study

Summary

This observational study aims to compare disease burden and pain characteristics between fibromyalgia patients with high levels of autoreactive autoantibodies, fibromyalgia patients with low levels of autoreactive autoantibodies, and healthy controls. The primary hypothesis is that patients experience more symptoms (as measured with questionnaires) depending on their antibody titer, and that high levels of autoantibodies correlate with other biological markers, such as inflammatory profile in serum, and density of intraepidermal nerve fibers in skin.

The secondary aim of this study is to characterize central markers of disease, which will be done using a number of methods: the investigators will quantify immune profile in the cerebrospinal fluid, measure thalamic neurotransmitter levels with magnetic resonance spectroscopy (MRS), blood-brain barrier permeability with both biochemical markers and T1-weighed gadolinium-enhanced magnetic resonance imaging (MRI), and resting state activity of the brain (MRI). The investigators hypothesize that there are signs of upregulation of the immune system of the central compartment, and that this will be correlated with altered neurotransmitter levels and an altered resting state activity.

Conditions

  • Fibromyalgia

Sponsors & Collaborators

  • Uppsala University

    lead OTHER

Principal Investigators

  • Eva Kosek, MD, PhD · Uppsala University, Karolinska Institutet

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2025-06-11
Completion
2025-12-18

Countries

  • Sweden

Study Locations

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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 NCT07346950 on ClinicalTrials.gov