Health TrialsbyHealthPanel

Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder

ConditionSomatic Symptom Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient with somatic symptom disorder (confirmed by psychiatrists)

Age 20-70

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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)

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: High-frequency rTMS at left DLPFCExperimental treatment 1 intervention
Group B: High-frequency sham stimulation at left DLPFCSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Scores of Health Anxiety Questionnaire (HAQ)

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

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

Secondary outcomes

1

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

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

Scores of Health Anxiety Questionnaire (HAQ)

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

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

Scores of Beck Depression Inventory-II (BDI-II)

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

Time frame
Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
4

Scores of Beck Anxiety Inventory (BAI)

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now