Somatic Symptom DisorderNCT05161819
Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder
A study testing Repetitive transcranial magnetic stimulation in people with Somatic Symptom Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Somatic Symptom Disorder
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Aug 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with somatic symptom disorder (confirmed by psychiatrists)
- Age 20-70
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Yunlin Branch
Douliu, Yunlin, 640
Wei-Lieh Huang, MD, PhD, weiliehhuang@gmail.com
Wei-Lieh Huang, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Somatic Symptom Disorder
- Being tested
- Repetitive transcranial magnetic stimulation, Sham stimulation
- Keywords
- somatic symptom disorder, repetitive transcranial magnetic stimulation, dorsolateral prefrontal cortex, somatic distress, health anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationDevice
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses
Sham stimulationDevice
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses (with sham coil)
| Study group | Role | What they receive |
|---|---|---|
| High-frequency rTMS at left DLPFC | Experimental | Receive an rTMS course with high-frequency stimulation at left DLPFC Receives: 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 Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measurement of somatic distress. Score range is 0 to 30; higher score means more severe somatic distress
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Skin conductance
Measurement of sympathetic activity
Measured: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start29 Aug 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatic Symptom DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Lieh Huang, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161819
- Sponsor's protocol ID
- 202109065DINC
- Status last verified
- Mar 2026
- First submitted
- 5 Dec 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder: A Randomized Double-blind Sham-controlled Crossover Study
- ClinicalTrials.gov ID
- NCT05161819
- Acronym / sponsor ID
- 202109065DINC
- Conditions
- Somatic Symptom Disorder
- Keywords
- somatic symptom disorder, repetitive transcranial magnetic stimulation, dorsolateral prefrontal cortex, somatic distress, health anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-frequency rTMS at left DLPFC | Experimental | Device: Repetitive transcranial magnetic stimulationReceive an rTMS course with high-frequency stimulation at left DLPFC |
| High-frequency sham stimulation at left DLPFC | Sham comparator | Device: Sham stimulationReceive an sham rTMS course with high-frequency stimulation at left DLPFC with the sham coil |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with somatic symptom disorder (confirmed by psychiatrists)
- Age 20-70
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive transcranial magnetic stimulationHigh-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses | Device | High-frequency rTMS at left DLPFC |
| Sham stimulationHigh-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses (with sham coil) | Device | High-frequency sham stimulation at left DLPFC |
Primary outcome
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
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
7 secondary outcomes
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)
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)
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)
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)
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)
Heart rate variability
Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Skin conductance
Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Somatic Symptom Disorder
RecruitingObservational study
Precision-Based Genomics in Prostate Cancer
Prostate Cancer
Active, not recruiting
Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
Safety, Psychological, Acceptability of Health Care
RecruitingPhase 2
A 52-Week Study Evaluating the Efficacy and Safety of Arumakimig (MAS825) in Participants With VEXAS Followed by Open-Label Extension (OLE) Period
VEXAS Syndrome
Recruiting
Stress Management and Meditative Movements for Asian Americans With Depression and Physical Symptoms
Depression / Major Depressive Disorder, Mental Health (Depression)
Recruiting
Ultra-brief Psychological Treatments for Emotional Symptoms and Disorders
Depression - Major Depressive Disorder, Generalized Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei-Lieh Huang, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Somatic Symptom Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei-Lieh Huang, MD, PhD (886-5-5323911 ext. 7101, weiliehhuang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.