NCT01683136

Brief Summary

This is an open study.approximately 20 patients diagnosed with Borderline Personality Disorder (in case patient is under drug treatment, treatment should be stable within the prior 4 weeks before study entry).Starting from the third day, subjects would undergo rTMS (repetitive Transcranial Magnetic Stimulation) for five days a week, for four weeks, and will be clinically evaluated in order to monitor for improvement. The investigators anticipate a significant reduction in symptoms severity at the end of the treatment compared to study entry.

Trial Health

55
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Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 21, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

1.5 years

First QC Date

August 21, 2012

Last Update Submit

September 6, 2012

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in ZAN-BPD

    every 2 weeks, up to 4 weeks.

Study Arms (2)

Deep TMS treatment

EXPERIMENTAL
Device: HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)

inactive stimulation

SHAM COMPARATOR
Device: HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)

Interventions

HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)DEVICE

on the first day subjects will be randomized to receive sham stimulation or real stimulation. subject who received real stimulation on the first day will receive sham stimulation on the second day. Likewise, Subjects who received sham stimulation on the first day will receive real stimulation on the second day. After receiving stimulation subjects will perform a facemorph task which evaluates their empathic capabilities. From the third treatment all subjects will recive a real stimulaitiobn: a session of rdTMS includes 4 cycles of 5 minutes of stimulation at a frequency of 10 Hz to the supplementary motor cortex and then a 20 seconds recess.each subject would undergo 5 sessions a week for 4 weeks

Deep TMS treatmentinactive stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and woman between the ages of 18-60
  • Diagnosed as suffering from Borderline Personality Disorder according to the DSM IV, as determined by a senior psychiatrist on the basis of the Structured Clinical Interview for DSM-IV Axis I
  • pharmocological treatment stays constant for the duration of the study
  • Gave informed consent for participation in the study
  • Not pregnant

You may not qualify if:

  • Electroconvulsive therapy (ECT) less than 9 months prior to screening.
  • suicide risk (assessed by the patient's doctor)
  • Suffer from active AXIS I disorder (according to the DSM IV)during the 3 months before study entry(besides: eating disorder, phobia and somatoform disorder)
  • History of seizure or heat convulsion.
  • History of epilepsy or seizure in first degree relatives.
  • History of head injury.
  • History of any metal in the head (outside the mouth).
  • Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
  • History of frequent or severe headaches.
  • History of migraine.
  • History of hearing loss.
  • Pregnancy or not using a reliable method of birth control.
  • Inadequate communication with the patient.
  • Under custodial care.
  • Participation in current clinical study or
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalvata Mental Health Center

Hod HaSharon, Israel

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Officials

  • Hagai Harari, MD

    Shalvata Mental Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilik Levkovitz, Prof.

CONTACT

972-9-7478568ylevk@clalit.org.il

Hila Gvirts, MA

CONTACT

972-9-7478644hilagv@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2012

First Posted

September 11, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2014

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations

IL(1)