Borderline Personality Disorder Clinical Trial
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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