Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

May 16, 2012
May 18, 2012
February 2012
July 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01602497 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Borderline Personality Disorder
  • Device: rTMS
    Patients undergone 10 session of high-frequency rTMS therapy over their left DLPFC
    Other Name: repetitive transcranial magnetic stimulation
  • Device: sham rTMS
    Patients will undergo ten session of sham rTMS.
    Other Name: sham repetitive transcranial magnetic stimulation
  • Active Comparator: rTMS intervention group
    The rTMS intervention group undergo ten session of real TMS therapy.
    Intervention: Device: rTMS
  • Placebo Comparator: Sham group
    Patients will undergo ten session of sham rTMS.
    Intervention: Device: sham rTMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
40
December 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinically diagnosed borderline personality disorder according to DSM IV.

Exclusion Criteria:

  • Epilepsy
  • Any metal device
  • Psychotic disorders
  • Bipolar mood disorder type 1
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01602497
90-01-30-13200
Yes
Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
Study Director: Mohammad Arbabi, M.D. Tehran University of Medical Sciences
Tehran University of Medical Sciences
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP