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Efficacy of rTMS (Repetitive Transcranial Magnetic Stimulation) on Patients With Somatoform Pain Disorder

Primary Purpose

Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring chronic pain, pain disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • DSM-IV diagnosis of somatoform pain disorder, chronic

Exclusion Criteria:

  • Neurological disorder
  • history of epilepsy

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

high frequency rTMS applied to the motor cortex

Outcomes

Primary Outcome Measures

The short form McGill Pain Questionnaire

Secondary Outcome Measures

functional brain MRI
Clinical Global Impression
Hamilton Depression and Anxiety Rating Scales

Full Information

First Posted
July 30, 2008
Last Updated
July 21, 2011
Sponsor
Samsung Medical Center
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00726791
Brief Title
Efficacy of rTMS (Repetitive Transcranial Magnetic Stimulation) on Patients With Somatoform Pain Disorder
Official Title
Efficacy of rTMS (Repetitive Transcranial Magnetic Stimulation) on Patients With Somatoform Pain Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Withdrawn
Why Stopped
patient did not enroll
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Chronic somatoform pain is common in psychiatric patients. Chronic somatoform pain causes significant distress and disrupts social functioning. Moreover, chronic somatoform pain often does not sufficiently respond to medication. Chronic somatoform pain is associated with medial pain system. The medial pain system is comprised of structures engaged in affect and motivation, such as medial thalamus and limbic structures. The medial pain system gets inhibitory control from motor cortex. Functional neuroimaging studies indicate that chronic somatoform pain is associated with hypoactivity of motor cortex, defective inhibitory process, and hyperactivity of medial pain system. Repetitive Transcranial Magnetic Stimulation (rTMS) is a safe and non-invasive tool to modulate neurophysiologic activity of the focal brain. Therefore, pain relief by rTMS can be obtained from motor cortex stimulation, restoration of defective inhibitory process, and deactivation of medial pain system. Studies have shown that motor cortex stimulation using rTMS can relieve pain in patients with neuropathic pain. However, to our knowledge, there is no rTMS study on chronic somatoform pain in psychiatric patients. The purpose of this study is to evaluate the effect of motor cortex rTMS on chronic somatoform pain.
Detailed Description
Chronic somatoform pain is common in psychiatric patients. Chronic somatoform pain causes significant distress and disrupts social functioning. Moreover, chronic somatoform pain often does not sufficiently respond to medication. Chronic somatoform pain is associated with medial pain system. The medial pain system is comprised of structures engaged in affect and motivation, such as medial thalamus and limbic structures. The medial pain system gets inhibitory control from motor cortex. Functional neuroimaging studies indicate that chronic somatoform pain is associated with hypoactivity of motor cortex, defective inhibitory process, and hyperactivity of medial pain system. Repetitive Transcranial Magnetic Stimulation (rTMS) is a safe and non-invasive tool to modulate neurophysiologic activity of the focal brain. Therefore, pain relief by rTMS can be obtained from motor cortex stimulation, restoration of defective inhibitory process, and deactivation of medial pain system. Studies have shown that motor cortex stimulation using rTMS can relieve pain in patients with neuropathic pain. However, to our knowledge, there is no rTMS study on chronic somatoform pain in psychiatric patients. The purpose of this study is to evaluate the effect of motor cortex rTMS on chronic somatoform pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
chronic pain, pain disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
high frequency rTMS applied to the motor cortex
Intervention Type
Device
Intervention Name(s)
repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
Patients receive high frequency rTMS applied to the motor cortex (M1 area). The treatment protocol consists of 10 sessions of rTMS. At each session, patients receive 30 stimulation trains (10 Hz, 4 sec, 100% motor threshold) with 26 sec inter-train interval, resulting in a total of 1200 pulses per session.
Primary Outcome Measure Information:
Title
The short form McGill Pain Questionnaire
Time Frame
baseline, mid-TMS, and after-TMS
Secondary Outcome Measure Information:
Title
functional brain MRI
Time Frame
baseline and after-TMS
Title
Clinical Global Impression
Time Frame
baseline, mid-TMS, and after-TMS
Title
Hamilton Depression and Anxiety Rating Scales
Time Frame
baseline, mid-TMS, and after-TMS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosis of somatoform pain disorder, chronic Exclusion Criteria: Neurological disorder history of epilepsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bum-Hee Yu, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

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Efficacy of rTMS (Repetitive Transcranial Magnetic Stimulation) on Patients With Somatoform Pain Disorder

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