Effect of Transcranial Magnetic Stimulation on Dorsomedial Cortex in Clinical and Neuropsychological Variables in Borderline Personality Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Borderline Symptoms List (BSL)
研究概览
简要总结
This study evaluates the effect of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) on Dorsomedial Prefrontal Cortex on Borderline Personality Disorder (BPD).
详细描述
Borderline Personality Disorder (BPD) is a mental illness with a high worldwide prevalence and economic costs, and is characterized with impulsiveness, both interpersonal relationships and emotional disturbance. Symptoms are related to hypofunction of frontal areas like Dorsomedial Prefrontal Cortex (DMPFC). Psychotherapy is the base treatment in this disease, but economic costs and long-time therapy have made difficult the attachment. Repetitive Transcranial Magnetic Stimulation(rTMS), authorized by Food and Drug Administration (FDA) on Major Depressive Disorder (MDD) treatment has proven good results in previous works in BPD clinical characteristics on both dorsolateral prefrontal cortex (DLPFC) and enhancement in depressive symptoms stimulating DMPFC in high frequency. However, there are no current research that have addressed the use of low-frequency on this anatomical area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-45 years old.
- •Meet DSM 5 (Diagnostic and Statistical Manual, 5th edition) diagnostic criteria for Borderline Personality Disorder.
- •Score of >7 in the Diagnostic Interview for Borderline (Revised version, DIB-R)
- •All patients must have follow-up psychotherapy of at least one month.
- •No changes on pharmacological treatment within the last month.
- •Patients must provide their oral and written informed consent.
排除标准
- •Subjects with history of traumatic brain injury with loss of consciousness.
- •Subjects with intracranial metallic objects or metal plates in the skull.
- •Subjects diagnosed with uncontrolled chronic (for example: hypertension, diabetes) or neurological diseases.
- •Comorbidity with other mental illness. (Except Depressive symptoms and Anxiety Disorders).
- •Presence of psychotic symptoms.
- •Alterations in the electroencephalogram (epileptiform activity).
- •Self injury or suicidal attempts in less than 2 weeks (depends on the severity and deepness).
研究组 & 干预措施
Placebo Stimulation
This group will receive the Sham modality simulating 1500 pulses of 5Hz Transcranial Magnetic Stimulation for 15 sessions, one per weekday.
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
5 Hz Stimulation
This group will receive 5Hz (Hertz) Dorsomedial Prefrontal Cortex repetitive Transcranial Magnetic Stimulation with 1500 pulses per session, once per weekday, with a final result of 15 sessions in this modality.
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Borderline Symptoms List (BSL)
时间窗: 6 weeks
BSL is a 23 item scale that evaluates the general symptoms and 11 items with behavioural evaluation of BPD.
Global Clinical Impression of BPD (GCI-BPD)
时间窗: 6 weeks
CGI-BPD is a 10 item evaluation that rates the severity of BPD distributed in 9 neuropsychological domains with a final global score.
Borderline Evaluation of Severity Over Time (BEST)
时间窗: 6 weeks
BEST is a 15 item scale that evaluates the severity in this pathology according to 3 areas: thoughts, emotions and typical behaviours.
次要结局
- Hamilton Anxiety Rating Scale (HARS)(6 weeks)
- Barratt Impulsivity Scale (BIS-11)(6 weeks)
- Hamilton Depression Rating Scale (HDRS)(6 weeks)
研究者
Dr. Julian Reyes López
Professor
Universidad Autonoma de Queretaro