Actively Recruiting
Intermittent Theta Burst Stimulation in Fibromyalgia Syndrome
Led by Izmir Katip Celebi University · Updated on 2025-03-18
30
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Intermittent Theta Burst Stimulation in Fibromyalgia Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 65 years old
- Diagnosed with fibromyalgia syndrome according to 2016 criteria
- Average pain intensity of at least 4 out of 10 on the Numeric Rating Scale
- Stable fibromyalgia treatment for the last 3 months with no planned treatment changes during the study
You will not qualify if you...
- Clinical conditions contraindicating TMS such as metallic implants, cardiac pacing, pregnancy, epilepsy, head trauma, or history of cranial surgery
- Presence of malignancy
- Systemic rheumatologic diseases
- Major orthopedic problems limiting daily activities, including gait disturbance, fracture sequelae, prostheses, or nerve-tendon injuries
- Serious neurological diseases including increased intracranial pressure, brain lesions, epilepsy history, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, or previous head trauma causing loss of consciousness
- Alcohol or drug addiction
- History of major depression, personality disorder, or psychosis
- Previous TMS treatment
- Taking or recently taken (within 4 weeks) benzodiazepines, gabapentin/pregabalin, or anticonvulsants that may interfere with iTBS
- Pregnant, planning pregnancy, or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Izmir Katip Çelebi University Atatürk Training and Research Hospital
Izmir, Karabaglar, Turkey (Türkiye), 35290
Actively Recruiting
Research Team
A
Ayhan ASKIN, Professor
CONTACT
E
Ezgi Ayan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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