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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00726791
• Collaborator: AstraZeneca (Industry)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 14
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Device: repetitive Transcranial Magnetic Stimulation (rTMS)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of rTMS (Repetitive Transcranial Magnetic Stimulation) on Patients With Somatoform Pain Disorder
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. The short form McGill Pain Questionnaire [baseline, mid-TMS, and after-TMS]

Secondary Outcome Measures

1. functional brain MRI [baseline and after-TMS]

2. Clinical Global Impression [baseline, mid-TMS, and after-TMS]

3. Hamilton Depression and Anxiety Rating Scales [baseline, mid-TMS, and after-TMS]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• DSM-IV diagnosis of somatoform pain disorder, chronic

Exclusion Criteria:

• Neurological disorder

• history of epilepsy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00726791
• Other Study ID Numbers: SMC IRB 2008-02-071
• First Posted: Aug 1, 2008
• Last Update Posted: Jul 25, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: chronic pain; pain disorder
• Additional relevant MeSH terms: Somatoform Disorders

Study Results

No Results Posted as of Jul 25, 2011