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

This study has been withdrawn prior to enrollment.
(patient did not enroll)
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00726791
First received: July 30, 2008
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Pain
Device: repetitive Transcranial Magnetic Stimulation (rTMS)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of rTMS (Repetitive Transcranial Magnetic Stimulation) on Patients With Somatoform Pain Disorder

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • The short form McGill Pain Questionnaire [ Time Frame: baseline, mid-TMS, and after-TMS ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • functional brain MRI [ Time Frame: baseline and after-TMS ] [ Designated as safety issue: Yes ]
  • Clinical Global Impression [ Time Frame: baseline, mid-TMS, and after-TMS ] [ Designated as safety issue: Yes ]
  • Hamilton Depression and Anxiety Rating Scales [ Time Frame: baseline, mid-TMS, and after-TMS ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: April 2008
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
high frequency rTMS applied to the motor cortex
Device: repetitive Transcranial Magnetic Stimulation (rTMS)
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of somatoform pain disorder, chronic

Exclusion Criteria:

  • Neurological disorder
  • history of epilepsy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726791

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
AstraZeneca
Investigators
Principal Investigator: Bum-Hee Yu, M.D., Ph.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Bum-Hee Yu, M.D. Ph.D. / Professor, Department of Psychiatry, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00726791     History of Changes
Other Study ID Numbers: SMC IRB 2008-02-071
Study First Received: July 30, 2008
Last Updated: July 21, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
chronic pain
pain disorder

Additional relevant MeSH terms:
Somatoform Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014