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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-frequency rTMS at left DLPFC | Experimental | Receive an rTMS course with high-frequency stimulation at left DLPFC |
|
| High-frequency sham stimulation at left DLPFC | Sham Comparator | Receive an sham rTMS course with high-frequency stimulation at left DLPFC with the sham coil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive transcranial magnetic stimulation | Device | High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Week 3 (comparing with the data in week 0) of the two sections (rTMS and sham) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 1, 2 (comparing with the data in week 0) of the two sections (rTMS and sham) |
| Scores of Health Anxiety Questionnaire (HAQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei-Lieh Huang, MD, PhD | Contact | 886-5-5323911 | 7101 | weiliehhuang@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei-Lieh Huang, MD, PhD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Yunlin Branch | Recruiting | Douliu | Yunlin | 640 | Taiwan |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Sham stimulation | Device | High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses (with sham coil) |
|
Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety |
| 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 | 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 | 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 | 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 | Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham) |
| Skin conductance | Measurement of sympathetic activity | Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham) |