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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2008

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 1
    • high frequency rTMS applied to the motor cortex

Clinical Trial Outcome Measures

Primary Measures

  • The short form McGill Pain Questionnaire
    • Time Frame: baseline, mid-TMS, and after-TMS

Secondary Measures

  • functional brain MRI
    • Time Frame: baseline and after-TMS
  • Clinical Global Impression
    • Time Frame: baseline, mid-TMS, and after-TMS
  • Hamilton Depression and Anxiety Rating Scales
    • Time Frame: baseline, mid-TMS, and after-TMS

Participating in This Clinical Trial

Inclusion Criteria

  • DSM-IV diagnosis of somatoform pain disorder, chronic Exclusion Criteria:

  • Neurological disorder – history of epilepsy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Samsung Medical Center
  • Collaborator
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Bum-Hee Yu, M.D. Ph.D. / Professor, Department of Psychiatry, Samsung Medical Center
  • Overall Official(s)
    • Bum-Hee Yu, M.D., Ph.D., Principal Investigator, Samsung Medical Center

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