NCT01602497

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 21, 2012

Status Verified

May 1, 2012

Enrollment Period

5 months

First QC Date

May 16, 2012

Last Update Submit

May 18, 2012

Conditions

Borderline Personality Disorder

Keywords

Borderline personality disorderrepetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • Patients' reports

    changes in subjective measures from baseline to tenth day of treatment

    Change from baseline to two weeks

Secondary Outcomes (2)

  • patient's report

    Change from baseline to 1 month

  • Patient's report

    Change from baseline to 3 month

Study Arms (2)

rTMS intervention group

ACTIVE COMPARATOR

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

Device: rTMS

Sham group

PLACEBO COMPARATOR

Patients will undergo ten session of sham rTMS.

Device: sham rTMS

Interventions

rTMSDEVICE

Patients undergone 10 session of high-frequency rTMS therapy over their left DLPFC

Also known as: repetitive transcranial magnetic stimulation
rTMS intervention group
sham rTMSDEVICE

Patients will undergo ten session of sham rTMS.

Also known as: sham repetitive transcranial magnetic stimulation
Sham group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically diagnosed borderline personality disorder according to DSM IV.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Mohammad Arbabi, M.D.

    Tehran University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2012

First Posted

May 21, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2012

Study Completion

December 1, 2012

Last Updated

May 21, 2012

Record last verified: 2012-05