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NCT Number: NCT05161819

Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital Yunlin Branch

Douliu, Yunlin, 640, Taiwan

Location status: Recruiting

Location contact

Wei-Lieh Huang, MD, PhD

CONTACT

[email protected]

Wei-Lieh Huang, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses

Sham stimulation

Device

High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses (with sham coil)

Primary outcomes

  1. 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)

    Measurement of somatic distress. Score range is 0 to 30; higher score means more severe somatic distress

  2. Scores of Health Anxiety Questionnaire (HAQ)

    Time frame: 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 outcomes

  1. 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)

    Measurement of somatic distress. Score range is 0 to 30; higher score means more severe somatic distress

  2. 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)

    Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety

  3. 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)

    Measurement of depression. Score range is 0 to 63; higher score means more severe depression

  4. 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)

    Measurement of anxiety. Score range is 0 to 63; higher score means more severe anxiety

  5. 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)

    Measurement of cognitions about health. Score range is 0 to 117; higher score means more severe cognitive distortion about health

  6. Heart rate variability

    Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)

    Measurement of parasympathetic activity

  7. Skin conductance

    Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)

    Measurement of sympathetic activity

Study contacts

Contact information is provided by the study sponsor or research team.

Wei-Lieh Huang, MD, PhD

CONTACT

[email protected]

886-5-5323911 ext. 7101

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2021
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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