Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder: A Randomized Double-blind Sham-controlled Crossover Study

Conditions
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Somatic Symptom Disorder

Intervention / Treatment
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* Device: Repetitive transcranial magnetic stimulation
* Device: Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with somatic symptom disorder (confirmed by psychiatrists) Age 20-70 Exclusion Criteria: Having psychotic symptoms or cognitive impairment Having potentially lethal illness Using cardiac pacemakers or defibrillators Currently pregnant or having plans to become pregnant within the next three months Received rTMS treatment within three months Cannot read the questionnaires by oneself Having to take the following medications persistently: bupropion >300 mg/day、TCA、clozapine、chlorpromazine、foscarnet、ganciclovir、ritonavir、theophylline

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-frequency rTMS at left DLPFC<br>Receive an rTMS course with high-frequency stimulation at left DLPFC | Device: Repetitive transcranial magnetic stimulation<br>* High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses<br>|
| Sham Comparator: High-frequency sham stimulation at left DLPFC<br>Receive an sham rTMS course with high-frequency stimulation at left DLPFC with the sham coil | Device: Sham stimulation<br>* High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses (with sham coil)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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somatic distress, health anxiety, somatic symptom disorder, repetitive transcranial magnetic stimulation, dorsolateral prefrontal cortex