Ignite Creation Date:
2024-05-06 @ 12:55 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01683136
Status:
UNKNOWN
Last Update Posted:
2012-09-11
First Post:
2012-08-21
Brief Title:
Evaluation of the HBDL Coil Transcranial Magnetic Stimulation TMS Device - Feasibility Study for the Treatment of Borderline Personality Disorder
Sponsor:
Shalvata Mental Health Center
Organization:
Shalvata Mental Health Center
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2012-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open studyapproximately 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 entryStarting 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 investigators anticipate a significant reduction in symptoms severity at the end of the treatment compared to study entry
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 recessTotal number of pulses 1200approximately 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 borderlines 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
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 recessTotal number of pulses 1200approximately 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 borderlines 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None