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

Primary Purpose

Borderline Personality Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rTMS
sham rTMS
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline personality disorder, repetitive transcranial magnetic stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically diagnosed borderline personality disorder according to DSM IV.

Exclusion Criteria:

  • Epilepsy
  • Any metal device
  • Psychotic disorders
  • Bipolar mood disorder type 1

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    rTMS intervention group

    Sham group

    Arm Description

    The rTMS intervention group undergo ten session of real TMS therapy.

    Patients will undergo ten session of sham rTMS.

    Outcomes

    Primary Outcome Measures

    Patients' reports
    changes in subjective measures from baseline to tenth day of treatment

    Secondary Outcome Measures

    patient's report
    change in subjective measures from baseline to 1 month after treatment
    Patient's report
    change in subjective measures form baseline to 3 month after treatment

    Full Information

    First Posted
    May 16, 2012
    Last Updated
    May 18, 2012
    Sponsor
    Tehran University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01602497
    Brief Title
    Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder
    Official Title
    A Sham-controlled Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2012 (undefined)
    Primary Completion Date
    July 2012 (Anticipated)
    Study Completion Date
    December 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tehran University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Borderline Personality Disorder
    Keywords
    Borderline personality disorder, repetitive transcranial magnetic stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    rTMS intervention group
    Arm Type
    Active Comparator
    Arm Description
    The rTMS intervention group undergo ten session of real TMS therapy.
    Arm Title
    Sham group
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will undergo ten session of sham rTMS.
    Intervention Type
    Device
    Intervention Name(s)
    rTMS
    Other Intervention Name(s)
    repetitive transcranial magnetic stimulation
    Intervention Description
    Patients undergone 10 session of high-frequency rTMS therapy over their left DLPFC
    Intervention Type
    Device
    Intervention Name(s)
    sham rTMS
    Other Intervention Name(s)
    sham repetitive transcranial magnetic stimulation
    Intervention Description
    Patients will undergo ten session of sham rTMS.
    Primary Outcome Measure Information:
    Title
    Patients' reports
    Description
    changes in subjective measures from baseline to tenth day of treatment
    Time Frame
    Change from baseline to two weeks
    Secondary Outcome Measure Information:
    Title
    patient's report
    Description
    change in subjective measures from baseline to 1 month after treatment
    Time Frame
    Change from baseline to 1 month
    Title
    Patient's report
    Description
    change in subjective measures form baseline to 3 month after treatment
    Time Frame
    Change from baseline to 3 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammad Arbabi, M.D.
    Organizational Affiliation
    Tehran University of Medical Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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