The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention (Observational Study).
- Who it may be relevant to
- Registry conditions: Fibromyalgia. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor (BDNF) Levels and Central Sensitization and Sleep Quality in Patients With Fibromyalgia
Overview
Fibromyalgia is a chronic pain syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive symptoms. Central sensitization is considered a key mechanism in the pathophysiology of fibromyalgia; however, the underlying biological markers have not been fully clarified. Brain-derived neurotrophic factor (BDNF) and S100B protein have been suggested to play roles in neuroinflammation and central pain processing. This observational, cross-sectional study aims to evaluate serum S100B and BDNF levels in patients with fibromyalgia and to investigate their relationship with central sensitization and sleep quality. Serum biomarker levels and clinical assessment scales will be compared between patients with fibromyalgia and healthy controls.
Detailed description
Fibromyalgia is a chronic pain syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive complaints. Central sensitization, defined as increased responsiveness of the central nervous system to sensory stimuli, is considered a core mechanism in the pathophysiology of fibromyalgia. However, the biological processes underlying central sensitization and associated clinical features such as sleep disturbances remain incompletely understood.
Brain-derived neurotrophic factor (BDNF) is a neurotrophin involved in synaptic plasticity, neuronal survival, and pain modulation, and has been suggested to be associated with central sensitization. S100B is a calcium-binding protein predominantly released by astrocytes and is considered a peripheral marker of neuroinflammation and glial activation. Alterations in serum levels of BDNF and S100B have been reported in chronic pain conditions, including fibromyalgia.
This observational, cross-sectional study aims to evaluate serum S100B and BDNF levels in patients diagnosed with fibromyalgia according to the 2016 American College of Rheumatology criteria and to investigate their relationship with central sensitization and sleep quality. A healthy control group matched for age and sex will be included for comparative analysis.
All participants will undergo a single-time-point assessment, including collection of demographic and clinical data. Blood samples will be obtained to measure serum S100B and BDNF levels using standard laboratory methods. Central sensitization will be assessed using the Central Sensitization Inventory, while sleep quality will be evaluated using the Pittsburgh Sleep Quality Index. Additional clinical assessments will include the Fibromyalgia Impact Questionnaire, Beck Depression Inventory, and Beck Anxiety Inventory.
The study does not involve any therapeutic intervention or randomization. The findings are expected to contribute to a better understanding of the biological correlates of central sensitization and sleep disturbances in fibromyalgia.
Interventions
- Other No Intervention (Observational Study)
This is an observational study with no therapeutic or diagnostic intervention. Participants will undergo a single-time-point clinical assessment and venous blood sampling for biomarker measurement only.
Primary outcome measures
- Association between serum S100B and serum BDNF [Time frame: Baseline]
Secondary outcome measures (2)
- Correlation of serum S100B and BDNF with Central Sensitization Inventory (CSI) [Time frame: Baseline]
- Correlation of serum S100B and BDNF with Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Female participants aged between 18 and 50 years
Diagnosis of fibromyalgia according to 2016 American College of Rheumatology (ACR) criteria
Symptoms present for at least 3 months
Ability to understand and complete study questionnaires
Provision of written informed consent
For healthy controls:
No diagnosis of fibromyalgia or chronic widespread pain
No known systemic disease
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Turkey (Türkiye) · 1 center
- Kanuni Sultan Süleyman Training and Research Hospital — Istanbul
Identifiers
NCT: NCT07358754 · KSS-EAH-FMS-S100B-BDNF-2026