Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repetitive transcranial magnetic stimulation, Sham stimulation.
- Who it may be relevant to
- Registry conditions: Somatic Symptom Disorder. Basic parameters: 20 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder: A Randomized Double-blind Sham-controlled Crossover Study
Overview
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
- Device Repetitive transcranial magnetic stimulation
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses - Device Sham stimulation
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses (with sham coil)
Primary outcome measures
- Scores of Patient Health Questionnaire-15 (PHQ-15) [Time frame: Week 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
- Scores of Health Anxiety Questionnaire (HAQ) [Time frame: Week 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
Secondary outcome measures (7)
- Scores of Patient Health Questionnaire-15 (PHQ-15) [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) [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) [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) [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) [Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
- Heart rate variability [Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
- Skin conductance [Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital Yunlin Branch — Douliu
Identifiers
NCT: NCT05161819 · 202109065DINC