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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01602497
First received: May 16, 2012
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention
Borderline Personality Disorder
Device: rTMS
Device: sham rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Sham-controlled Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder Patients

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Patients' reports [ Time Frame: Change from baseline to two weeks ] [ Designated as safety issue: Yes ]
    changes in subjective measures from baseline to tenth day of treatment


Secondary Outcome Measures:
  • patient's report [ Time Frame: Change from baseline to 1 month ] [ Designated as safety issue: Yes ]
    change in subjective measures from baseline to 1 month after treatment

  • Patient's report [ Time Frame: Change from baseline to 3 month ] [ Designated as safety issue: Yes ]
    change in subjective measures form baseline to 3 month after treatment


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rTMS intervention group
The rTMS intervention group undergo ten session of real TMS therapy.
Device: rTMS
Patients undergone 10 session of high-frequency rTMS therapy over their left DLPFC
Other Name: repetitive transcranial magnetic stimulation
Placebo Comparator: Sham group
Patients will undergo ten session of sham rTMS.
Device: sham rTMS
Patients will undergo ten session of sham rTMS.
Other Name: sham repetitive transcranial magnetic stimulation

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically diagnosed borderline personality disorder according to DSM IV.

Exclusion Criteria:

  • Epilepsy
  • Any metal device
  • Psychotic disorders
  • Bipolar mood disorder type 1
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602497

Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Director: Mohammad Arbabi, M.D. Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01602497     History of Changes
Other Study ID Numbers: 90-01-30-13200
Study First Received: May 16, 2012
Last Updated: May 18, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
Borderline personality disorder
repetitive transcranial magnetic stimulation

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014