NCT05161819

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Aug 2022Dec 2026

First Submitted

Initial submission to the registry

December 5, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

August 29, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

4.3 years

First QC Date

December 5, 2021

Last Update Submit

March 16, 2026

Conditions

Somatic Symptom Disorder

Keywords

somatic symptom disorderrepetitive transcranial magnetic stimulationdorsolateral prefrontal cortexsomatic distresshealth anxiety

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • 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)

  • Scores of Health Anxiety Questionnaire (HAQ)

    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)

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

  • Scores of Beck Anxiety Inventory (BAI)

    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)

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

  • +2 more secondary outcomes

Study Arms (2)

High-frequency rTMS at left DLPFC

EXPERIMENTAL

Receive an rTMS course with high-frequency stimulation at left DLPFC

Device: Repetitive transcranial magnetic stimulation

High-frequency sham stimulation at left DLPFC

SHAM COMPARATOR

Receive an sham rTMS course with high-frequency stimulation at left DLPFC with the sham coil

Device: Sham stimulation

Interventions

Sham stimulationDEVICE

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

High-frequency sham stimulation at left DLPFC
Repetitive transcranial magnetic stimulationDEVICE

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

High-frequency rTMS at left DLPFC

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Yunlin Branch

Douliu, Yunlin, 640, Taiwan

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Wei-Lieh Huang, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Lieh Huang, MD, PhD

CONTACT

886-5-5323911weiliehhuang@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2021

First Posted

December 17, 2021

Study Start

August 29, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)