Intermittent Theta Burst Stimulation in Fibromyalgia Syndrome

Launched by IZMIR KATIP CELEBI UNIVERSITY · Dec 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option called intermittent theta burst stimulation (iTBS) for people with fibromyalgia syndrome, a condition that causes widespread pain and fatigue. The goal is to see if this therapy can help reduce pain and improve quality of life for patients. Researchers will enroll at least 30 adults, aged 18 to 65, who have been diagnosed with fibromyalgia and have been stable on their current treatments for at least three months.

Participants in the trial will be randomly assigned to receive either the iTBS treatment or a placebo (sham treatment) over ten sessions. Throughout the study, patients will continue their usual fibromyalgia care. The researchers will use several questionnaires to assess pain levels, the impact of fibromyalgia on daily life, and any feelings of anxiety or depression. This study is important because it aims to provide more evidence about the effectiveness of iTBS for fibromyalgia, as there is currently limited research available on this treatment approach.

Gender

ALL

Eligibility criteria

• 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