Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:

A Sham-controlled Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01602497
• Other study ID #: 90-01-30-13200
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 16, 2012
• Last updated: May 18, 2012
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: May 2012
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study is going to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on Borderline Personality Disorder patients symptoms.

Description:

There is a great body of literature about the positive effects of rTMS therapy on various psychiatric disorders. In this study we are going to evaluate the effects of high-frequency rTMS over the left dorsolateral prefrontal cortex (DLPFC)region in borderline personality disorder (BPD) patients. patients will be assessed by subjective measures for BPD.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinically diagnosed borderline personality disorder according to DSM IV.

Exclusion Criteria:

• Epilepsy

• Any metal device

• Psychotic disorders

• Bipolar mood disorder type 1

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Device:
• rTMS
Patients undergone 10 session of high-frequency rTMS therapy over their left DLPFC
• sham rTMS
Patients will undergo ten session of sham rTMS.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' reports	changes in subjective measures from baseline to tenth day of treatment	Change from baseline to two weeks	Yes
Secondary	patient's report	change in subjective measures from baseline to 1 month after treatment	Change from baseline to 1 month	Yes
Secondary	Patient's report	change in subjective measures form baseline to 3 month after treatment	Change from baseline to 3 month	Yes