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Intermittent Theta Burst Stimulation in Fibromyalgia Syndrome

RecruitingNAAges 18 Years - 65 YearsAllIzmir Katip Celebi University
NCT06746922 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Research on repetitive transcranial magnetic stimulation therapy in fibromyalgia syndrome (FMS) is increasing rapidly. High-frequency rTMS administration to FMS patients is reported to restore intracortical facilitation and provide successful pain relief. This finding supports restoration of cortical stimulation as one of the possible mechanisms of action for rTMS. One treatment protocol is intermittent theta burst stimulation (iTBS, a variant of excitatory rTMS). Although there are many treatment protocols, there are few widely accepted treatment schemes in the literature. In fibromyalgia syndrome, there is no study in the literature. It was planned to include at least 30 patients aged 18-65 years who were admitted to İzmir Katip Çelebi University Atatürk Training and Research Hospital Physical Medicine and Rehabilitation Outpatient Clinic or hospitalized in the ward and diagnosed with

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📋 Eligibility rules (as published)
Inclusion Criteria: * Being between the ages of 18-65 * Being diagnosed with fibromyalgia syndrome (according to 2016 criteria) * Average pain intensity of NRS ≥ 4/10 * Fibromyalgia treatment was stable for the last 3 months and no treatment change was planned during the study Exclusion Criteria: * Having a clinical condition that would constitute a contraindication for TMS (metallic implant, cardiac pacing, pregnancy, epilepsy, head trauma, history of cranial operation...) * Presence of malignancy * Systemic rheumatologic diseases * Major orthopedic problems limiting activities of daily living (gait disturbance or fracture sequelae limiting joint mobility, prostheses, nerve-tendon injuries) * Serious neurological diseases (increased intracranial pressure, presence of space-occupying lesions in the brain, history of epilepsy, presence of cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, history of previous head trauma causing loss of consciousness) * Alcohol or drug addiction * History of major depression/personality disorder or psychosis * Having received TMS treatment before * Taking benzodiazepine, gabapentin/pregabalin or anticonvulsant medications that have the potential to interfere with intermittent theta burst stimulation treatment or have taken them within the last 4 weeks * Pregnant or planning pregnancy or breastfeeding
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What it tests

  • Intermittent theta-burst stimulation
  • Sham Intermittent theta-burst stimulation
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Where

1 site
Izmir Katip Çelebi University Atatürk Training and Research Hospital
Izmir, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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