Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder

Not Applicable

Recruiting

• Conditions: Somatic Symptom Disorder
• Interventions: Device: Sham stimulation; Device: Repetitive transcranial magnetic stimulation

• Registration Number: NCT05161819
• Lead Sponsor: National Taiwan University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-05
• Study First Submitted QC: 2021-12-05
• Study First Posted: 2021-12-17
• Study Start: 2022-08-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient with somatic symptom disorder (confirmed by psychiatrists)
• Age 20-70

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High-frequency sham stimulation at left DLPFC	Sham stimulation	Receive an sham rTMS course with high-frequency stimulation at left DLPFC with the sham coil
High-frequency rTMS at left DLPFC	Repetitive transcranial magnetic stimulation	Receive an rTMS course with high-frequency stimulation at left DLPFC

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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 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
Skin conductance	Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)	Measurement of sympathetic activity
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 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

Trial Locations

Locations (1)

National Taiwan University Hospital Yunlin Branch; 🇨🇳 Douliu, Yunlin, Taiwan