RecruitingNot ApplicableNCT06746922

Intermittent Theta Burst Stimulation in Fibromyalgia Syndrome

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

Sponsor

Izmir Katip Celebi University

Enrollment

30 participants

Start Date

Mar 13, 2025

Study Type

INTERVENTIONAL

Conditions

Pain Fibromyalgia Transcranial Magnetic Stimulation Repetitive

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of brain stimulation therapy called intermittent theta burst stimulation (iTBS) — a non-invasive treatment that uses magnetic pulses to target areas of the brain linked to pain — in people with fibromyalgia, a condition that causes widespread, long-lasting pain. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with fibromyalgia (using 2016 diagnostic criteria) - Your average pain level is at least 4 out of 10 - Your fibromyalgia treatment has been stable for at least 3 months and is not expected to change during the study **You may NOT be eligible if...** - You have a metal implant, pacemaker, or have had brain surgery (which would make the magnetic stimulation unsafe) - You have epilepsy or a history of seizures - You have cancer, a serious neurological disease, or a major rheumatological condition - You have a history of severe depression, psychosis, or personality disorder - You are pregnant, planning to become pregnant, or breastfeeding - You have had TMS treatment before - You are currently taking certain medications like benzodiazepines, gabapentin, pregabalin, or anticonvulsants (or took them in the past 4 weeks) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEIntermittent theta-burst stimulation

Neuro-MS/D (Neurosoft) rTMS device will be used for stimulation with an angulated figure-of-eight coil. Neuronavigation system will be used to determine the application site. Before each session, active motor threshold (aMT) will be determined by obtaining a motor evoked potential with an amplitude of \>200μV in the EMG recording of the first dorsal interosseous muscle (FDI), which is slightly contracted (10-20% of maximum contraction) in at least five out of 10 stimuli delivered to the primary motor cortex. The handle will be held at a 45° angle to the sagittal plane, pointing backwards and laterally to create posterior-anterior current flow in the brain. The stimulation parameters are as follows: Parameters: Stimulation type:Burst Stimulus amplitude (% MT): 80 Burst frequency in sequence (Hz):5 Pulse frequency within burst (Hz):50 Number of bursts in the sequence: 10 Number of series:20 Interval between sequences: 8 sec Total time: 3min 47sec Total number of pulses: 600

DEVICESham Intermittent theta-burst stimulation

In the sham application, the probe of the transcranial magnetic stimulation device will be placed in the vertical position and held perpendicular to the vertex and applied at an ineffective dose so that the patient hears the same sound. In order for the device to produce the same sound and warning sounds as the active application, it will be operated at the lowest operating power of 1 power. In the device operating at this power, there is no possibility of any warning due to the upright position of the probe.