Using intermittent theta burst stimulation to treat fibromyalgia
The Effect of Intermittent Theta Burst Stimulation to the Primary Motor Cortex on Pain Intensity, Pain Catastrophizing, Quality of Life and Mood in Fibromyalgia Patients
This study is testing if a new brain stimulation technique can help people with fibromyalgia feel less pain and manage their symptoms better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Izmir Katip Celebi University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Izmir, Karabaglar) |
| Trial ID | NCT06746922 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of intermittent theta burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation (rTMS), on patients diagnosed with fibromyalgia syndrome. It aims to include at least 30 participants aged 18-65 who have been experiencing chronic pain and other symptoms associated with fibromyalgia. The study will compare the effects of active iTBS treatment against a sham treatment to evaluate its efficacy in pain relief and symptom management. The research is being conducted at İzmir Katip Çelebi University Atatürk Training and Research Hospital, focusing on a population that has stable fibromyalgia treatment for the past three months.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 diagnosed with fibromyalgia syndrome and experiencing moderate to severe pain.
Not a fit: Patients with contraindications for transcranial magnetic stimulation, such as those with metallic implants or serious neurological conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improve the quality of life for patients suffering from fibromyalgia.
How similar studies have performed: While there is increasing research on rTMS for fibromyalgia, this specific approach using iTBS is relatively novel and has not been widely tested in the literature.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Izmir, Karabaglar
- Izmir Katip Çelebi University Atatürk Training and Research Hospital — Izmir, Karabaglar, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ayhan ASKIN, Professor
- Email: ayhan.askin@ikc.edu.tr
- Phone: 902322444444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.