Initial Evaluation of Efficacy and Adverse Events of Single Lesions in Bilateral Ventral-capsular and Ventral Capsulotomy-striatal by Linear Accelerator Radiosurgery in Severe and Refractory Obsessive-compulsive Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in OCD symptoms
研究概览
简要总结
The aim of this study is to evaluate, through a pilot study with about ten cases, if bilateral ventral capsulotomy by linear accelerator enable modification of obsessive-compulsive symptoms and quality of life in patients with severe and refractory obsessive compulsive disorder (OCD) and also investigate possible adverse effects / complications of the procedure.
详细描述
About ten patients with severe and refractory OCD will receive bilateral single lesions at the bottom of the anterior limb of the internal capsule by linear accelerator. Prior to the procedure, a detailed clinical and psychiatric evaluation, plus an extensive battery of psychiatric diagnostic tests, severity and progression of OCD, depression / anxiety symptoms, presence of tics, psychosocial impairment, quality of life, familial accommodation and neuropsychological and personality testes will be performed. Furthermore, the patients will be also assessed by serological and neuroimaging tests. The Individuals will be periodically evaluated and followed up for one year. The results of the scores of the rating scales will be analyzed and compared, as well as the profile of adverse events, cognitive or personality changes and improves in clinical tests and neuroimaging 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OCD diagnosis, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as a major disease entity. If comorbidity with other psychiatric or personality disorders, OCD symptoms dominate the clinical picture and precede other disorders.
- •Duration of OCD symptoms of at least five years.
- •Scores range of the obsessive-compulsive symptoms "Yale-Brown Obsessive-Compulsive Scale" (YBOCS) greater than 26 (or greater than 13, if obsessions or compulsions alone).
- •Fill up the criteria for refractory to prior treatments.
- •Be accepted by the method of "best estimate" for defining the patient is refractory, which consisted of confirmation by at least two specialists obsessive-compulsive disorder that the patient fulfills the criteria for effective refractory to previous treatments.
排除标准
- •History of head trauma or post-traumatic amnesia.
- •Background of systemic or neurological diseases with brain impairment, severe and active.
- •History of current use of substances capable of inducing psychopathological manifestations, or signs of cumulative effects of alcohol or drugs in the central nervous system (such as cortical atrophy), confirmed by neuroimaging.
- •pregnancy or lactation.
- •Refusal to submit to the radiosurgical procedure.
- •Refusal to accept the informed consent form, or participate.
- •History of mental retardation and / or inability to understand the informed consent, confirmed by neuropsychological tests of the initial evaluation.
- •Lack of family or companion with proper capacity of understanding of the informed consent in patients with comorbid major depression or psychosis that could potentially have difficulty performing the appropriate judgment as to participate in the study.
研究组 & 干预措施
Treatment
Radiosurgery by linear accelerator.
干预措施: Radiosurgery (Radiation)
结局指标
主要结局
Change in OCD symptoms
时间窗: Every 3 months until 12 months
Application of Yale-Brown Obsessive-Compulsive Scale (Y-Bocs) scale
次要结局
- Change in OCD symptoms by CPRS(Every 3 months)
- Change in quality of life.(Every 3 months until 12 months)
- Change in brain-derived neurotrophic factor (BDNF) blood dosing(12 months)
- Side effects and complications(Every 3 months until 12 months)
- Change in near-infrared spectroscopy (NIRS) brain blood flow(12 months)
- Change in familial accommodation(Every 3 months until 12 months)
- Change in depressive symptoms.(Every 3 months until 12 months)
- Change in psychological tests(12 months)
- Change in OCD symptoms by NIMH.(Every 3 months)
- Change in Global Functioning(Every 3 months until 12 months)
- Change in anxiety symptoms.(Every 3 months until 12 months)