FibromyalgiaS100B-BDNFNCT07358754
The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor
An observational study of Fibromyalgia, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Presence of any systemic disease (hematologic, endocrine, rheumatologic, renal, cardiovascular, gastrointestinal, or respiratory) Active infection History of malignancy Major surgery or trauma within the last 1 year Any treatment for fibromyalgia within the last 3 months Pregnancy or breastfeeding Smoking Vitamin D deficiency
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul
Zeynep Karakuzu Güngör, M.D, 905077750375, zeynepkarakuzu@hotmail.com.tr
About this study
Official title: The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor (BDNF) Levels and Central Sensitization and Sleep Quality in Patients With Fibromyalgia
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- No Intervention (Observational Study)
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia Group | Female patients aged 18-50 years diagnosed with fibromyalgia according to the 2016 American College of Rheumatology criteria. Receives: Other: No Intervention (Observational Study) | |
| Healthy Control Group | Age- and sex-matched healthy female volunteers without fibromyalgia or chronic widespread pain. Receives: Other: No Intervention (Observational Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between serum S100B and serum BDNF
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
Measured: Baseline
Secondary outcomes (2)
Correlation of serum S100B and BDNF with Central Sensitization Inventory (CSI)
Serum S100B and BDNF levels will be correlated with CSI total score to evaluate biomarker association with central sensitization severity.
Measured: Baseline
Correlation of serum S100B and BDNF with Pittsburgh Sleep Quality Index (PSQI)
Serum S100B and BDNF levels will be correlated with PSQI total score to evaluate association with sleep quality.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Feb 2026
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Karakuzu Güngör, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Zeynep Karakuzu Güngör, M.D, Principal investigator, Kanuni Sultan Süleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358754
- Sponsor's protocol ID
- KSS-EAH-FMS-S100B-BDNF-2026
- Acronym
- S100B-BDNF
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly. De-identified aggregate data may be made available upon reasonable request from the corresponding author after publication of the study results.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor (BDNF) Levels and Central Sensitization and Sleep Quality in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07358754
- Acronym / sponsor ID
- S100B-BDNF / KSS-EAH-FMS-S100B-BDNF-2026
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia Group | – | Other: No Intervention (Observational Study)Female patients aged 18-50 years diagnosed with fibromyalgia according to the 2016 American College of Rheumatology criteria. |
| Healthy Control Group | – | Other: No Intervention (Observational Study)Age- and sex-matched healthy female volunteers without fibromyalgia or chronic widespread pain. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Presence of any systemic disease (hematologic, endocrine, rheumatologic, renal, cardiovascular, gastrointestinal, or respiratory) Active infection History of malignancy Major surgery or trauma within the last 1 year Any treatment for fibromyalgia within the last 3 months Pregnancy or breastfeeding Smoking Vitamin D deficiency
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Fibromyalgia Group, Healthy Control Group |
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly. De-identified aggregate data may be made available upon reasonable request from the corresponding author after publication of the study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeynep Karakuzu Güngör, M.D principal investigator
Kanuni Sultan Süleyman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Karakuzu Güngör, M.D (905077750375, zeynepkarakuzu@hotmail.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between serum S100B and serum BDNF (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.