Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Feasibility Study for the Treatment of Borderline Personality Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from Baseline in ZAN-BPD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 .
结局指标
主要结局
Change from Baseline in ZAN-BPD
时间窗: every 2 weeks, up to 4 weeks.
次要结局
未报告次要终点