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

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ClinicalTrials.gov Identifier: NCT00726791
Recruitment Status : Withdrawn (patient did not enroll)
First Posted : August 1, 2008
Last Update Posted : July 25, 2011
Sponsor:
Collaborator:
Information provided by:

July 30, 2008
August 1, 2008
July 25, 2011
April 2008
December 2008   (Final data collection date for primary outcome measure)
The short form McGill Pain Questionnaire [ Time Frame: baseline, mid-TMS, and after-TMS ]
Same as current
Complete list of historical versions of study NCT00726791 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy of rTMS (Repetitive Transcranial Magnetic Stimulation) on Patients With Somatoform Pain Disorder
Efficacy of rTMS (Repetitive Transcranial Magnetic Stimulation) on Patients With Somatoform Pain Disorder

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pain
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.
Experimental: 1
high frequency rTMS applied to the motor cortex
Intervention: Device: repetitive Transcranial Magnetic Stimulation (rTMS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
10
June 2009
December 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • DSM-IV diagnosis of somatoform pain disorder, chronic

Exclusion Criteria:

  • Neurological disorder
  • history of epilepsy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00726791
SMC IRB 2008-02-071
Yes
Not Provided
Not Provided
Bum-Hee Yu, M.D. Ph.D. / Professor, Department of Psychiatry, Samsung Medical Center
Samsung Medical Center
AstraZeneca
Principal Investigator: Bum-Hee Yu, M.D., Ph.D. Samsung Medical Center
Samsung Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP