Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Feasibility Study for the Treatment of Borderline Personality Disorder

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by Shalvata Mental Health Center
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01683136
First received: August 21, 2012
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Borderline Personality Disorder
Device: HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • Change from Baseline in ZAN-BPD [ Time Frame: every 2 weeks, up to 4 weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deep TMS treatment Device: HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)

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

Sham Comparator: inactive stimulation Device: HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)

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


Detailed Description:

The symptoms of borderline personality disorder can be treated, but there is no known cure.

Several recent studies have shown that patients suffering from borderline personality disorder (BPD) express a significant hypoactivity and smaller gray matter concentration in the anterior cingulate cortex (ACC), compared to healthy controls.

In this current study we are attempting to find a better solution for the treatment of Borderline Personality Disorder using deep Transcranial magnetic stimulation (dTMS) technology.

The HBDL coil is intended to induce activation of prefrontal and orbitofrontal brain structures, including the ACC, in order to induce long term potentiation in this brain region.

The protocol includes bilateral stimulation to the SMA at 110% of the motor threshold of the Abductor Policies Brevis and at a frequency of 10 Hz. each session is comprised of four cycles of 3 seconds of stimulation and a 20 seconds recess(Total number of pulses: 1200).approximately 20 patients diagnosed with Borderline Personality Disorder will participate. subjects would undergo rTMS sessions for five days a week, for four weeks, using the HBDL dTMS coil. this coil is capable of producing a magnetic field in deeper parts of the cerebral cortex, and for that reason we believe that it can produce better clinical outcomes then superficial TMS coils used in earlier studies.

The goal of this study is to determine the safety and efficacy of transcranial magnetic stimulation (TMS) in treating patients suffering from borderline personality disorder.

Our main objective is to observe a reduction in the severity of the symptoms post treatment in comparison to pre treatment, using the zan-bpd as the main outcome measure. Additional objective is to observe normalizaition of borderline's empathic tendencies: on one hand, we expect their affective empathy to be compromised post treatment in comparison to pre treatment. on the other hand, we expect heir cognitive empathy to be increased post treatment in comparison to pre treatment.

Note that 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.

the 20 day of treatments will be started from the third day.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • A significant physical illness which is not balanced.
  • Cerebral Palsy, history of encephalitis or other structural brain damage.
  • Pseudotumor cerebri
  • neurological deficit
  • Patients using high dosage of antipsychotic medicine :

more than 7.5 mg Haldol, 10 mg Olanzapine, 4 mg Risperdal, 400 mg SEROQUEL, 120 mg Geodon, 100 mg Clopixol, 12 mg Perphenan.

Patients taking Clozapine will not be recruited to the present study In case of taking other antipsychotic medicine besides those listed above, the principal investigator will decide whether patients are eligible for recruitment .

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683136

Contacts
Contact: Hilik Levkovitz, Prof. 972-9-7478568 ylevk@clalit.org.il
Contact: Hila Gvirts, MA 972-9-7478644 hilagv@clalit.org.il

Locations
Israel
Shalvata Mental Health Center Not yet recruiting
Hod Hasharon,, Israel
Contact: Hillik Levkovitz, Prof    972-9-7478568    ylevk@clalit.org.il   
Contact: Hagai Harari, MD    972-9-7478500    rreh@clalit.org.il   
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
Principal Investigator: Hagai Harari, MD Shalvata Mental Health Center
  More Information

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01683136     History of Changes
Other Study ID Numbers: SHA-09-11
Study First Received: August 21, 2012
Last Updated: September 6, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Borderline Personality Disorder
Personality Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014