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NCT Number: NCT07358754

The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Zeynep Karakuzu Güngör, M.D

CONTACT

[email protected]

905077750375

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

No intervention (observational study)

Other

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 outcomes

  1. Association between serum S100B and serum BDNF

    Time frame: Baseline

    Serum S100B and serum BDNF concentrations will be measured from venous blood samples and the strength of association between the two biomarkers will be analyzed

Secondary outcomes

  1. Correlation of serum S100B and BDNF with Central Sensitization Inventory (CSI)

    Time frame: Baseline

    Serum S100B and BDNF levels will be correlated with CSI total score to evaluate biomarker association with central sensitization severity.

  2. Correlation of serum S100B and BDNF with Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline

    Serum S100B and BDNF levels will be correlated with PSQI total score to evaluate association with sleep quality.

Study contacts

Contact information is provided by the study sponsor or research team.

Zeynep Karakuzu Güngör, M.D

CONTACT

[email protected]

905077750375

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor (BDNF) Levels and Central Sensitization and Sleep Quality in Patients With Fibromyalgia

Acronym: S100B-BDNF

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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