Somatic Symptom Disorder
Conditions
Keywords
somatic symptom disorder, repetitive transcranial magnetic stimulation, dorsolateral prefrontal cortex, somatic distress, health anxiety
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.
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.
Interventions
DEVICERepetitive transcranial magnetic stimulation
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses
DEVICESham stimulation
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses (with sham coil)
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Taiwan
Contacts
CONTACTWei-Lieh Huang, MD, PhD
PRINCIPAL_INVESTIGATORWei-Lieh Huang, MD, PhD
National Taiwan University Hospital
Outcome results
None listed