Borderline Personality DisorderNCT01683136
Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Feasibility Study for the Treatment of Borderline Personality Disorder
A study testing HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS) in people with Borderline Personality Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 22Show fewer
- 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 .
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shalvata Mental Health Center
Hod HaSharon
Hillik Levkovitz, Prof, 972-9-7478568, ylevk@clalit.org.il
Hagai Harari, MD, 972-9-7478500, rreh@clalit.org.il
About this study
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.
Read the 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Deep TMS treatment | Experimental | Not described Receives: Device: HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS) |
| inactive stimulation | Sham comparator | Not described Receives: Device: HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in ZAN-BPD
Measured: every 2 weeks, up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hagai Harari, MD, Principal investigator, Shalvata Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683136
- Sponsor's protocol ID
- SHA-09-11
- Status last verified
- Sep 2012
- First submitted
- 21 Aug 2012
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Feasibility Study for the Treatment of Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT01683136
- Acronym / sponsor ID
- SHA-09-11
- Conditions
- Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2014 (estimated)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Deep TMS treatment, inactive stimulation |
Primary outcome
Change from Baseline in ZAN-BPD
Time frame: every 2 weeks, up to 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hagai Harari, MD principal investigator
Shalvata Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS) in people with Borderline Personality Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilik Levkovitz, Prof. (972-9-7478568, ylevk@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in ZAN-BPD (time frame: every 2 weeks, up to 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2012.