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

May 18, 2012 updated by: Tehran University of Medical Sciences

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • sham repetitive transcranial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' reports
Time Frame: Change from baseline to two weeks
changes in subjective measures from baseline to tenth day of treatment
Change from baseline to two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient's report
Time Frame: Change from baseline to 1 month
change in subjective measures from baseline to 1 month after treatment
Change from baseline to 1 month
Patient's report
Time Frame: Change from baseline to 3 month
change in subjective measures form baseline to 3 month after treatment
Change from baseline to 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Study Director: Mohammad Arbabi, M.D., Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ANTICIPATED)

July 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

May 16, 2012

First Submitted That Met QC Criteria

May 18, 2012

First Posted (ESTIMATE)

May 21, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 21, 2012

Last Update Submitted That Met QC Criteria

May 18, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90-01-30-13200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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