Intermittent Theta Burst Stimulation in Fibromyalgia Syndrome

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 13, 2025

Primary Completion Date

February 1, 2027

Study Completion Date

April 1, 2027

Conditions
FibromyalgiaTranscranial Magnetic Stimulation RepetitivePain
Interventions
DEVICE

Intermittent 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"

DEVICE

Sham 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.

Trial Locations (1)

35290

RECRUITING

Izmir Katip Çelebi University Atatürk Training and Research Hospital, Izmir

All Listed Sponsors
lead

Izmir Katip Celebi University

OTHER