The Effect of Autoreactive Autoantibodies on Peripheral and Central Disease Mechanisms in Fibromyalgia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Anti-SGC antibodies
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female sex
- •Age 20-70
- •Fibromyalgia according to the ACR 1990+2016 criteria for the FM cohort.
排除标准
- •Reported BMI > 35 during screening over a phone call.
- •Other dominant chronic pain states.
- •Autoimmune diseases (exception: primary hypothyroidism).
- •Serious somatic or psychiatric disease.
- •Current pregnancy.
- •Non-fluency in Swedish.
- •For HC: history of chronic pain or current pain exceeding 20 on a 0-100 scale or having received an FM diagnosis.
- •For NINS: having received an FM diagnosis.
研究组 & 干预措施
CSF controls
A cohort consisting of 1) healthy controls (n = 11) recruited in another study and 2) patients with non-inflammatory neurological symptoms (NINS, n = 32) that underwent clinical workup at the neurological clinic at Uppsala University Hospital.
HC
Control participants that have no pain condition. No cerebrospinal fluid was collected from this cohort.
FM
Participants with fibromyalgia according to the ACR 1990+2016 criteria.
结局指标
主要结局
Anti-SGC antibodies
时间窗: At study inclusion.
Autoantibodies that bind to satellite glia cells in the dorsal root ganglia. The investigators hypothesize that autoantibody titers are associated with symptom severity (Goebel et al., 2021; Krock et al., 2023; Fanton et al., 2023), changes in inflammatory profile (af Ekenstam et al., 2025) and alterations in skin histological findings.
次要结局
- Neurotransmitter levels in the right thalamus(At study inclusion.)
- Inflammatory profile in serum(At study inclusion.)
- Inflammatory profile in cerebrospinal fluid(At study inclusion.)
- CSF-serum albumin quotients(At study inclusion.)
- Quantitative sensory testing (QST)(At study inclusion.)
- Intraepidermal nerve fiber density (IENFD) in skin(At study inclusion.)
- Polysomnography(At study inclusion.)
- Resting state functional magnetic resonance imaging (rsfMRI)(At study inclusion.)
- Blood-brain barrier dynamics(At study inclusion.)