Repetitive Transcranial Magnetic Stimulation in Borderline Personality Disorder Patients. Effects in Clinical Measurements, Inhibition, Cognitive Flexibility, and Social Cognition Process
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from Baseline in BORDERLINE EVALUATION OF SEVERITY OVER TIME (BEST)
研究概览
简要总结
The purpose of this study is to determine the potential effects of repetitive transcranial magnetic stimulation in the improvement of neuropsychological deficits and symptomatology in borderline personality disorder patients. Specially in cognitive flexibility, inhibition control and social cognition.
详细描述
This is a randomized, parallel group clinical trial to evaluate the efficacy of two protocols of repetitive Transcranial Magnetic Stimulation (rTMS), the application will be over dorsolateral prefrontal cortex (DLPFC) right and left, in patients with borderline personality disorder. 40 ambulatory patients with a borderline personality disorder diagnosis from the National Institute of Psychiatry in México will be included. All Patients will be randomly assigned and will complete a total of 23 sessions rTMS, in any of two groups:
5 Hz Group.- This group will receive rTMS sessions, 5 per week during three weeks (acute treatment phase), and after that, one session a week for the next eight weeks (follow up). The rTMS will be applied over the left DLPFC at 5 Hz, 1500 pulses per session in 100% of Motor threshold
1 Hz Group.- This group will receive rTMS sessions, 5 per week during three weeks (acute treatment phase), and after that, one session a week for the next eight weeks (follow up).
The rTMS will be applied over the right DLPFC at 1 Hz, 900 pulses per session in 100% of Motor threshold All sessions will be applied with a "Dantec" transcranial magnetic stimulator. The affective, borderline and anxiety symptoms will be evaluated at baseline, and every 5 TMS sessions during the acute treatment phase, and once at the end of the 8-weeks follow up. In same form for neuropsychological evaluations .
Categorical variables will be described by percentages and frequencies. Continuous variables will be described by means and standard deviations. Treatment groups will be compared using Student's T test. Cognitive, anxiety, borderline and affective symptom scale scores between treatment groups will be compared using repeated measures ANOVA
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Diagnosis of borderline personality disorder according to diagnostic and statistical manual of mental disorders IV text revision
- •Treatment with selective inhibitors of serotonin reuptake
- •Mass corporal index more than 19
排除标准
- •Suicide risk or suicide attempt recent or actual
- •History of epilepsy or seizures
- •History of cranial trauma with loss awareness
- •Intracranial or intraocular ferromagnetic devices, including skull prosthesis.
- •Pregnant womens.
- •Neurosurgery, cardiac pacemaker, lefthander
- •Patients with psychotic symptoms, bipolar disorder or substance addiction.
结局指标
主要结局
Change from Baseline in BORDERLINE EVALUATION OF SEVERITY OVER TIME (BEST)
时间窗: Inclusion, after 15 days of treatment and at 8 weeks follow up
The Borderline Evaluation of Severity Over Time (BEST) was developed to rate the thoughts, emotions, and behaviors typical of borderline personality disorder.
次要结局
- Change from Baseline in Hamilton Depression rating scale(Inclusion, after 15 days of treatment and at 8 weeks follow up)
- Change from Baseline in Stop Signal Task (SST)(Inclusion, after 15 days of treatment and at 8 weeks follow up)
- Change from Baseline in Wisconsin card sorting test (WCST)(Inclusion, after 15 days of treatment and at 8 weeks follow up)
- Change from Baseline in Reading the Mind in the Eyes Test(Inclusion, after 15 days of treatment and at 8 weeks follow up)
- Change from Baseline in Barratt impulsiveness scale(IInclusion, after 15 days of treatment and at 8 weeks follow up)
研究者
Julian Reyes Lopez
Medical doctor Psychiatry
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente