Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High-frequency rTMS at left DLPFC Receive an rTMS course with high-frequency stimulation at left DLPFC |
Device: Repetitive transcranial magnetic stimulation
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses
|
| Sham Comparator: High-frequency sham stimulation at left DLPFC 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 (with sham coil)
|
Outcome Measures
Primary Outcome Measures
- Scores of Patient Health Questionnaire-15 (PHQ-15) [Week 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
Measurement of somatic distress. Score range is 0 to 30; higher score means more severe somatic distress
- Scores of Health Anxiety Questionnaire (HAQ) [Week 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety
Secondary Outcome Measures
- Scores of Patient Health Questionnaire-15 (PHQ-15) [Week 1, 2 (comparing with the data in week 0) of the two sections (rTMS and sham)]
Measurement of somatic distress. Score range is 0 to 30; higher score means more severe somatic distress
- Scores of Health Anxiety Questionnaire (HAQ) [Week 1, 2 (comparing with the data in week 0) of the two sections (rTMS and sham)]
Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety
- Scores of Beck Depression Inventory-II (BDI-II) [Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
Measurement of depression. Score range is 0 to 63; higher score means more severe depression
- Scores of Beck Anxiety Inventory (BAI) [Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
Measurement of anxiety. Score range is 0 to 63; higher score means more severe anxiety
- Scores of Cognitions About Body and Health Questionnaire (CABAH) [Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
Measurement of cognitions about health. Score range is 0 to 117; higher score means more severe cognitive distortion about health
- Heart rate variability [Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
Measurement of parasympathetic activity
- Skin conductance [Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
Measurement of sympathetic activity
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient with somatic symptom disorder (confirmed by psychiatrists)
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Age 20-70
Exclusion Criteria:
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Having psychotic symptoms or cognitive impairment
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Having potentially lethal illness
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Using cardiac pacemakers or defibrillators
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Currently pregnant or having plans to become pregnant within the next three months
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Received rTMS treatment within three months
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Cannot read the questionnaires by oneself
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Having to take the following medications persistently: bupropion >300 mg/day、TCA、clozapine、chlorpromazine、foscarnet、ganciclovir、ritonavir、theophylline
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Taiwan University Hospital Yunlin Branch | Douliu | Yunlin | Taiwan | 640 |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Principal Investigator: Wei-Lieh Huang, MD, PhD, National Taiwan University Hospital Yunlin Branch
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202109065DINC