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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014