Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-29

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Somatic Symptom Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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High-frequency rTMS at left DLPFC

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

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses

High-frequency sham stimulation at left DLPFC

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

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type DEVICE

High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses (with sham coil)

Interventions

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Repetitive transcranial magnetic stimulation

High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses

Intervention Type DEVICE

Sham stimulation

High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses (with sham coil)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No