An interventional study of Repetitive transcranial magnetic stimulation and Sham stimulation in Somatic Symptom Disorder, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
This is a randomized double-blind sham-controlled crossover study; the interventions are high-frequency rTMS stimulation on left DLPFC and sham control. The study population is the patient with somatic symptom disorder. The primary outcomes are somatic distress and health anxiety.
Somatic symptom disorder (SSD) is a psychiatric diagnosis featured with somatic distress and health anxiety. It is overlapped with functional disorders. Whether it has effective treatment is a clinically important issue. Current evidence indicates that pharmacotherapy and psychotherapy are both helpful for SSD. Among other treatment options, repetitive transcranial magnetic stimulation (rTMS) is attached important in psychiatric field; it can cause activation or inhibition of specific brain regions via magnetic stimulation. Previous studies have disclosed that rTMS is helpful for depression, obsessive-compulsive disorder, post-stroke rehabilitation, etc. Regarding functional disorders, fibromyalgia has been found to be benefited from rTMS; the effective approaches include giving high-frequency stimulation on left M1 and dorsolateral prefrontal cortex (DLPFC). Chronic tinnitus was also found to have response to rTMS. SSD and fibromyalgia are highly overlapped; SSD and depression are often comorbid. Therefore, SSD may also be benefited from left DLPFC high-frequency stimulation. Our previous study revealed that dysfunction of anterior cingulate cortex (ACC) is associated with persistent interference of the somatic discomforts; stimulation on DLPFC can cause ACC activation. This study program was designed based on the above information. It is a randomized double-blind sham-controlled crossover study; the interventions are high-frequency rTMS stimulation on left DLPFC and sham control. The primary outcomes are somatic distress and health anxiety. There is not study about rTMS on SSD in literature; the investigators expect this study to be able to provide more understanding on this field.
National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
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Exclusion Criteria:
Receive an rTMS course with high-frequency stimulation at left DLPFC
Device: Repetitive transcranial magnetic stimulation
Receive an sham rTMS course with high-frequency stimulation at left DLPFC with the sham coil
Device: Sham stimulation
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses (with sham coil)
Scores of Patient Health Questionnaire-15 (PHQ-15)
Measurement of somatic distress. Score range is 0 to 30; higher score means more severe somatic distress
Time frame: Week 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Scores of Health Anxiety Questionnaire (HAQ)
Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety
Time frame: Week 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Scores of Patient Health Questionnaire-15 (PHQ-15)
Measurement of somatic distress. Score range is 0 to 30; higher score means more severe somatic distress
Time frame: Week 1, 2 (comparing with the data in week 0) of the two sections (rTMS and sham)
Scores of Health Anxiety Questionnaire (HAQ)
Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety
Time frame: Week 1, 2 (comparing with the data in week 0) of the two sections (rTMS and sham)
Scores of Beck Depression Inventory-II (BDI-II)
Measurement of depression. Score range is 0 to 63; higher score means more severe depression
Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Scores of Beck Anxiety Inventory (BAI)
Measurement of anxiety. Score range is 0 to 63; higher score means more severe anxiety
Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Scores of Cognitions About Body and Health Questionnaire (CABAH)
Measurement of cognitions about health. Score range is 0 to 117; higher score means more severe cognitive distortion about health
Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Heart rate variability
Measurement of parasympathetic activity
Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Skin conductance
Measurement of sympathetic activity
Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Plan to share: No
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National Taiwan University Hospital