ClinicalTrials.Veeva

Menu

The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor (S100B-BDNF)

K

Kanuni Sultan Suleyman Training and Research Hospital

Status

Not yet enrolling

Conditions

Fibromyalgia

Treatments

Other: No Intervention (Observational Study)

Study type

Observational

Funder types

Other

Identifiers

NCT07358754
KSS-EAH-FMS-S100B-BDNF-2026

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

-

Trial design

60 participants in 2 patient groups

Fibromyalgia Group
Description:
Female patients aged 18-50 years diagnosed with fibromyalgia according to the 2016 American College of Rheumatology criteria.
Treatment:
Other: No Intervention (Observational Study)
Healthy Control Group
Description:
Age- and sex-matched healthy female volunteers without fibromyalgia or chronic widespread pain.
Treatment:
Other: No Intervention (Observational Study)

Trial contacts and locations

0

Loading...

Central trial contact

Zeynep Karakuzu Güngör, M.D

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems