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Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder

Primary Purpose

Somatic Symptom Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Sham stimulation
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Somatic Symptom Disorder focused on measuring somatic symptom disorder, repetitive transcranial magnetic stimulation, dorsolateral prefrontal cortex, somatic distress, health anxiety

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Taiwan University Hospital Yunlin BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

High-frequency rTMS at left DLPFC

High-frequency sham stimulation at left DLPFC

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Scores of Health Anxiety Questionnaire (HAQ)
Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety

Secondary Outcome Measures

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
Scores of Health Anxiety Questionnaire (HAQ)
Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety
Scores of Beck Depression Inventory-II (BDI-II)
Measurement of depression. Score range is 0 to 63; higher score means more severe depression
Scores of Beck Anxiety Inventory (BAI)
Measurement of anxiety. Score range is 0 to 63; higher score means more severe anxiety
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
Heart rate variability
Measurement of parasympathetic activity
Skin conductance
Measurement of sympathetic activity

Full Information

First Posted
December 5, 2021
Last Updated
August 31, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05161819
Brief Title
Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder
Official Title
Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder: A Randomized Double-blind Sham-controlled Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Somatic Symptom Disorder
Keywords
somatic symptom disorder, repetitive transcranial magnetic stimulation, dorsolateral prefrontal cortex, somatic distress, health anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-frequency rTMS at left DLPFC
Arm Type
Experimental
Arm Description
Receive an rTMS course with high-frequency stimulation at left DLPFC
Arm Title
High-frequency sham stimulation at left DLPFC
Arm Type
Sham Comparator
Arm Description
Receive an sham rTMS course with high-frequency stimulation at left DLPFC with the sham coil
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses (with sham coil)
Primary Outcome Measure Information:
Title
Scores of Patient Health Questionnaire-15 (PHQ-15)
Description
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)
Title
Scores of Health Anxiety Questionnaire (HAQ)
Description
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 Outcome Measure Information:
Title
Scores of Patient Health Questionnaire-15 (PHQ-15)
Description
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)
Title
Scores of Health Anxiety Questionnaire (HAQ)
Description
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)
Title
Scores of Beck Depression Inventory-II (BDI-II)
Description
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)
Title
Scores of Beck Anxiety Inventory (BAI)
Description
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)
Title
Scores of Cognitions About Body and Health Questionnaire (CABAH)
Description
Measurement of cognitions about health. Score range is 0 to 117; higher score means more severe cognitive distortion about health
Time Frame
Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Title
Heart rate variability
Description
Measurement of parasympathetic activity
Time Frame
Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Title
Skin conductance
Description
Measurement of sympathetic activity
Time Frame
Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Lieh Huang, MD, PhD
Phone
886-5-5323911
Ext
7101
Email
weiliehhuang@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Lieh Huang, MD, PhD
Organizational Affiliation
National Taiwan University Hospital Yunlin Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital Yunlin Branch
City
Douliu
State/Province
Yunlin
ZIP/Postal Code
640
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Lieh Huang, MD, PhD
Email
weiliehhuang@gmail.com
First Name & Middle Initial & Last Name & Degree
Wei-Lieh Huang, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder

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