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

NCT00726791 | Withdrawn DMC

• 1 other identifier: SMC IRB 2008-02-071
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

chronic pain; pain disorder

Outcome Measures

Primary Outcomes (1)

• The short form McGill Pain Questionnaire

  baseline, mid-TMS, and after-TMS

Secondary Outcomes (3)

• functional brain MRI

  baseline and after-TMS

• Clinical Global Impression

  baseline, mid-TMS, and after-TMS

• Hamilton Depression and Anxiety Rating Scales

  baseline, mid-TMS, and after-TMS

Study Arms (1)

1

EXPERIMENTAL

high frequency rTMS applied to the motor cortex

Device: repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-IV diagnosis of somatoform pain disorder, chronic

You may not qualify if:

• Neurological disorder
• history of epilepsy

Sponsors & Collaborators

• Samsung Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Pain; Chronic Pain; Somatoform Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Bum-Hee Yu, M.D., Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 1, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2009
• Last Updated: July 25, 2011

Record last verified: 2011-07

Locations

KR (1)