Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder

Somatic Symptom Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05161819
• Other study ID #: 202109065DINC
• Status: Recruiting
• Phase: N/A
• Start date: August 29, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: National Taiwan University Hospital
• Contact: Wei-Lieh Huang, MD, PhD
• Phone: 886-5-5323911
• Email: weiliehhuang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Medically Unexplained Symptoms
• Somatic Symptom Disorder

Intervention

Device:
• Repetitive transcranial magnetic stimulation
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses
• Sham stimulation
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses (with sham coil)

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Yunlin Branch	Douliu	Yunlin

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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 1, 2 (comparing with the data in week 0) of the two sections (rTMS and sham)
Secondary	Scores of Health Anxiety Questionnaire (HAQ)	Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety	Week 1, 2 (comparing with the data in week 0) of the two sections (rTMS and sham)
Secondary	Scores of Beck Depression Inventory-II (BDI-II)	Measurement of depression. Score range is 0 to 63; higher score means more severe depression	Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Secondary	Scores of Beck Anxiety Inventory (BAI)	Measurement of anxiety. Score range is 0 to 63; higher score means more severe anxiety	Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Secondary	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	Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Secondary	Heart rate variability	Measurement of parasympathetic activity	Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Secondary	Skin conductance	Measurement of sympathetic activity	Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)