Clinical trial NCT00726791: Efficacy of rTMS (Repetitive Transcranial Magnetic Stimulation) on Patients With Somatoform Pain Disorder
Official title: Efficacy of rTMS (Repetitive Transcranial Magnetic Stimulation) on Patients With Somatoform Pain Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain
Keywords: chronic pain
pain disorder
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2008-08-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of somatoform pain disorder, chronic

Exclusion Criteria:

* Neurological disorder
* history of epilepsy

Primary outcomes:
measure: The short form McGill Pain Questionnaire
timeFrame: baseline, mid-TMS, and after-TMS
Secondary outcomes:
measure: functional brain MRI
timeFrame: baseline and after-TMS
measure: Clinical Global Impression
timeFrame: baseline, mid-TMS, and after-TMS
measure: Hamilton Depression and Anxiety Rating Scales
timeFrame: baseline, mid-TMS, and after-TMS
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Bum-Hee Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: