[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620525":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":23,"studyPopulation":24,"armGroups":25,"interventions":35,"overallOfficials":40,"centralContacts":45,"locations":50,"responsibleParty":63,"collaborators":20,"id":66,"slug":20,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":20,"studyType":80,"phases":20,"briefSummary":81,"conditions":82,"keywords":20,"overallStatus":52,"whyStopped":20,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Kanuni Sultan Suleyman Training and Research Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"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","Baseline",[14,17],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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.",null,{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":6,"timePerspective":22,"maskingInfo":20},"PROSPECTIVE","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.\n\nBrain-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.\n\nThis 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.\n\nAll 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.\n\nThe 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.","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",[26,31],{"label":27,"type":20,"description":28,"interventionNames":29},"Fibromyalgia Group","Female patients aged 18-50 years diagnosed with fibromyalgia according to the 2016 American College of Rheumatology criteria.",[30],"Other: No Intervention (Observational Study)",{"label":32,"type":20,"description":33,"interventionNames":34},"Healthy Control Group","Age- and sex-matched healthy female volunteers without fibromyalgia or chronic widespread pain.",[30],[36],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":20},"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.",[27,32],[41],{"name":42,"affiliation":43,"role":44},"Zeynep Karakuzu Güngör, M.D","Kanuni Sultan Süleyman Training and Research Hospital","PRINCIPAL_INVESTIGATOR",[46],{"name":42,"role":47,"phone":48,"phoneExt":20,"email":49},"CONTACT","905077750375","zeynepkarakuzu@hotmail.com.tr",[51],{"facility":43,"status":52,"city":53,"state":20,"zip":20,"country":54,"countryCode":20,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Istanbul","Turkey (Türkiye)",{"type":56,"coordinates":57},"Point",[58,59],28.94966,41.01384,{"lat":59,"lon":58},[62],{"name":42,"role":47,"phone":48,"phoneExt":20,"email":49},{"type":44,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Zeynep Karakuzu Güngör","Physical Medicine and Rehabilitation Specialist","100620525",false,"NCT07358754","The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor","The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor (BDNF) Levels and Central Sensitization and Sleep Quality in Patients With Fibromyalgia","S100B-BDNF","Inclusion Criteria:\n\n* Female participants aged between 18 and 50 years\n\nDiagnosis of fibromyalgia according to 2016 American College of Rheumatology (ACR) criteria\n\nSymptoms present for at least 3 months\n\nAbility to understand and complete study questionnaires\n\nProvision of written informed consent\n\nFor healthy controls:\n\nNo diagnosis of fibromyalgia or chronic widespread pain\n\nNo known systemic disease\n\nExclusion Criteria:\n\n\\-",true,"FEMALE","18 Years","50 Years",{"count":78,"type":79},60,"ESTIMATED","OBSERVATIONAL","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.\n\nBrain-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.",[83],"Fibromyalgia","2026-04-10",{"date":86,"type":87},"2026-04-15","ACTUAL",{"date":89,"type":87},"2026-02-01",{"date":91,"type":79},"2026-04-30",{"name":5,"class":6},1]