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

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ClinicalTrials.gov Identifier: NCT01602497
Recruitment Status : Unknown
Verified May 2012 by Tehran University of Medical Sciences.
Recruitment status was:  Enrolling by invitation
First Posted : May 21, 2012
Last Update Posted : May 21, 2012
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

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

Condition or disease Intervention/treatment
Borderline Personality Disorder Device: rTMS Device: sham rTMS

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : February 2012
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Patients' reports [ Time Frame: Change from baseline to two weeks ]
    changes in subjective measures from baseline to tenth day of treatment


Secondary Outcome Measures :
  1. patient's report [ Time Frame: Change from baseline to 1 month ]
    change in subjective measures from baseline to 1 month after treatment

  2. Patient's report [ Time Frame: Change from baseline to 3 month ]
    change in subjective measures form baseline to 3 month after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602497


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

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01602497     History of Changes
Other Study ID Numbers: 90-01-30-13200
First Posted: May 21, 2012    Key Record Dates
Last Update Posted: May 21, 2012
Last Verified: May 2012

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

Additional relevant MeSH terms:
Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders