Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder

Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder: A Randomized Double-blind Sham-controlled Crossover Study

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.

Study Overview

• Status: Recruiting
• Conditions: Somatic Symptom Disorder
• Intervention / Treatment: Device: Repetitive transcranial magnetic stimulation; Device: Sham stimulation

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei-Lieh Huang, MD, PhD; Phone Number: 7101 886-5-5323911; Email: weiliehhuang@gmail.com

Study Locations

• Taiwan
  • Yunlin
    • Douliu, Yunlin, Taiwan, 640
      • Recruiting
      • National Taiwan University Hospital Yunlin Branch
      • Contact: Wei-Lieh Huang, MD, PhD; Email: weiliehhuang@gmail.com
      • Principal Investigator: Wei-Lieh Huang, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores of Patient Health Questionnaire-15 (PHQ-15)	Measurement of somatic distress. Score range is 0 to 30; higher score means more severe somatic distress	Week 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Scores of Health Anxiety Questionnaire (HAQ)	Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety	Week 3 (comparing with the data in week 0) of the two sections (rTMS and sham)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores of Patient Health Questionnaire-15 (PHQ-15)	Measurement of somatic distress. Score range is 0 to 30; higher score means more severe somatic distress	Week 1, 2 (comparing with the data in week 0) of the two sections (rTMS and sham)
Scores of Health Anxiety Questionnaire (HAQ)	Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety	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)	Measurement of depression. Score range is 0 to 63; higher score means more severe depression	Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Scores of Beck Anxiety Inventory (BAI)	Measurement of anxiety. Score range is 0 to 63; higher score means more severe anxiety	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)	Measurement of cognitions about health. Score range is 0 to 117; higher score means more severe cognitive distortion about health	Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Heart rate variability	Measurement of parasympathetic activity	Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Skin conductance	Measurement of sympathetic activity	Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Wei-Lieh Huang, MD, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 5, 2021
• First Submitted That Met QC Criteria: December 5, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: repetitive transcranial magnetic stimulation; dorsolateral prefrontal cortex; somatic symptom disorder; health anxiety; somatic distress
• Additional Relevant MeSH Terms: Pathologic Processes; Medically Unexplained Symptoms; Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: 202109065DINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No