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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00726791
• Other study ID #: SMC IRB 2008-02-071
• Status: Withdrawn
• Phase: N/A
• First received: July 30, 2008
• Last updated: July 21, 2011
• Start date: April 2008
• Est. completion date: June 2009

Study information

• Verified date: July 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 10
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• DSM-IV diagnosis of somatoform pain disorder, chronic

Exclusion Criteria:

• Neurological disorder

• history of epilepsy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The short form McGill Pain Questionnaire		baseline, mid-TMS, and after-TMS	Yes
Secondary	functional brain MRI		baseline and after-TMS	Yes
Secondary	Clinical Global Impression		baseline, mid-TMS, and after-TMS	Yes
Secondary	Hamilton Depression and Anxiety Rating Scales		baseline, mid-TMS, and after-TMS	Yes