Intermittent Theta Burst Stimulation in Fibromyalgia Syndrome
Recruiting · NCT06746922 · Interventional (participants receive a specific treatment) · Lead sponsor: Izmir Katip Celebi University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 fibromyalgia syndrome according to the 2016 criteria. This study has a prospective, parallel group, randomized, sham-controlled study design. A total of 30 fibromyalgia patients will be randomized into 2 groups and will receive a total of 10 sessions of transcranial magnetic stimulation to the primary motor cortex with intermittent theta bust stimulation technique or sham application. Patients will continue their current fibromyalgia treatment.Numeric Rating Scale-pain intensity (NRS-pain), revised Fibromyalgia Impact Questionnaire (FIQR), Pain Catastrophizing Scale (PCS), Hospital Depression Anxiety Scale (HADS) will be used in the evaluation of the patients.
Who can take part
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
Where it is running
1 location listed.
- Izmir Katip Çelebi University Atatürk Training and Research Hospital - Izmir, Karabaglar, Turkey (Türkiye)