Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder

National Taiwan University

Status: Enrolling

Conditions: Somatic Symptom Disorder

Treatments: Device: Sham stimulation; Device: Repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05161819

202109065DINC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

High-frequency rTMS at left DLPFC

Experimental group

Description:

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

Treatment:

Device: Repetitive transcranial magnetic stimulation

High-frequency sham stimulation at left DLPFC

Sham Comparator group

Description:

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

Treatment:

Device: Sham stimulation