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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Shalvata Mental Health Center.
Recruitment status was  Not yet recruiting
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

August 21, 2012
September 6, 2012
September 2012
March 2014   (final data collection date for primary outcome measure)
Change from Baseline in ZAN-BPD [ Time Frame: every 2 weeks, up to 4 weeks. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01683136 on ClinicalTrials.gov Archive Site
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Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Feasibility Study for the Treatment of Borderline Personality Disorder
Not Provided

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Borderline Personality Disorder
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

  • Experimental: Deep TMS treatment
    Intervention: Device: HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)
  • Sham Comparator: inactive stimulation
    Intervention: Device: HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
Not Provided
March 2014   (final data collection date for primary outcome measure)

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 .

Both
18 Years to 60 Years
No
Contact: Hilik Levkovitz, Prof. 972-9-7478568 ylevk@clalit.org.il
Contact: Hila Gvirts, MA 972-9-7478644 hilagv@clalit.org.il
Israel
 
NCT01683136
SHA-09-11
Yes
Shalvata Mental Health Center
Shalvata Mental Health Center
Not Provided
Principal Investigator: Hagai Harari, MD Shalvata Mental Health Center
Shalvata Mental Health Center
September 2012

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