Clinical trial NCT05161819: Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder
Official title: Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder: A Randomized Double-blind Sham-controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Somatic Symptom Disorder
Keywords: somatic symptom disorder
repetitive transcranial magnetic stimulation
dorsolateral prefrontal cortex
somatic distress
health anxiety
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Scores of Patient Health Questionnaire-15 (PHQ-15)
timeFrame: Week 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
measure: Scores of Health Anxiety Questionnaire (HAQ)
timeFrame: Week 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Secondary outcomes:
measure: Scores of Patient Health Questionnaire-15 (PHQ-15)
timeFrame: Week 1, 2 (comparing with the data in week 0) of the two sections (rTMS and sham)
measure: Scores of Health Anxiety Questionnaire (HAQ)
timeFrame: Week 1, 2 (comparing with the data in week 0) of the two sections (rTMS and sham)
measure: Scores of Beck Depression Inventory-II (BDI-II)
timeFrame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
measure: Scores of Beck Anxiety Inventory (BAI)
timeFrame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
measure: Scores of Cognitions About Body and Health Questionnaire (CABAH)
timeFrame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
measure: Heart rate variability
timeFrame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
measure: Skin conductance
timeFrame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: National Taiwan University Hospital Yunlin Branch
state: Yunlin
Study officials:
affiliation: National Taiwan University Hospital Yunlin Branch
name: Wei-Lieh Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: