Actively Recruiting
Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder: A Randomized Double-blind Sham-controlled Crossover Study
Led by National Taiwan University Hospital · Updated on 2026-03-18
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on patients with somatic symptom disorder (SSD), a condition characterized by somatic distress and health anxiety. SSD overlaps with functional disorders and often occurs alongside depression. The study investigates whether high-frequency rTMS applied to the left dorsolateral prefrontal cortex (DLPFC) can reduce symptoms of SSD. This is a randomized, double-blind, sham-controlled crossover study designed to provide new insights into this treatment approach. Participants will receive two types of interventions in separate periods: a course of high-frequency rTMS stimulation on the left DLPFC, and a sham stimulation using a sham coil but with similar high-frequency settings. Each session involves 10Hz stimulation at 120% motor threshold, with 40 trains and 1600 pulses. The study uses a crossover design, meaning each participant receives both the real and sham treatments in different phases while remaining unaware of the order. During the study, participants will be assessed at weeks 0, 1, 2, and 3 for symptoms of somatic distress and health anxiety using questionnaires such as the Patient Health Questionnaire-15 (PHQ-15) and the Health Anxiety Questionnaire (HAQ). Additional assessments include depression and anxiety inventories, cognitive questionnaires, heart rate variability, and skin conductance. The primary outcomes focus on changes at week 3 compared to baseline. This study includes careful monitoring to understand treatment effects and safety over the course of participation.
CONDITIONS
Brief Title
Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with somatic symptom disorder confirmed by psychiatrists
- Age between 20 and 70 years
You will not qualify if you...
- Having psychotic symptoms or cognitive impairment
- Having potentially lethal illness
- Using cardiac pacemakers or defibrillators
- Currently pregnant or planning to become pregnant within the next three months
- Received rTMS treatment within the past three months
- Unable to read the questionnaires independently
- Taking certain medications persistently such as bupropion >300 mg/day, TCA, clozapine, chlorpromazine, foscarnet, ganciclovir, ritonavir, or theophylline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each treatment course lasts 3 weeks
Participants receive two courses of repetitive transcranial magnetic stimulation (rTMS) or sham stimulation at left dorsolateral prefrontal cortex (DLPFC) in a randomized crossover design.
Weekly visits for up to 3 weeks per treatment course
Duration - Up to 3 weeks after each treatment course
Participants are monitored for changes in somatic distress and health anxiety after each treatment course.
Weekly visits for up to 3 weeks
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital Yunlin Branch
Douliu, Yunlin, Taiwan, 640
Actively Recruiting
Research Team
W
Wei-Lieh Huang, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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