Electric Neuromodulation in Refractory Obsessive-compulsive Disorder : the Montpellier Experience (France)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
研究概览
简要总结
Obsessive-compulsive disorder (OCD) is a neuropsychiatric disease characterised by intrusive, recurrent and persistent thoughts, urges or images (obsessions) and the resulting excessive repetitive behaviours or mental acts according to rigid rules unrealistically aimed at reducing distress (compulsions).
Its lifetime prevalence in the general population is usually estimated between 1 - 3% (Ruscio, Mol Psychiatry, 2010). Despite appropriate pharmacological and cognitive-behavioural treatments, it is commonly estimated that 10% of patients are therapy-refractory and that among improved or recovered patients, sustained efficacy is uncertain.
For treatment refractory OCD patients, a neurosurgical treatment by deep brain stimulation (DBS), has emerged in the late 1990s as a new therapeutic option (Nuttin et al, Lancet, 1999).
The objective of the current study is to report the long-term treatment effects (safety and effectiveness) of DBS from the cohort of six severe and therapy-refractory OCD patients implanted at the French university hospital of Montpellier since 2003.
详细描述
The data needed to carry out the study will be extracted from the medical files of the 6 patients concerned.
The following data will be collected:
- Age, sex
- Medical, surgical and psychiatric history
- History of pharmacological treatments
- Elements from clinical examination
- any reported adverse effect
- scores of the various questionnaires completed throughout the follow-up (including Y-BOCS and GAF)
- results of biological, morphological, neuropsychological tests
- Stimulation parameters applied since implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
时间窗: 12 months
10-item scale with scores ranging from 0 to 40; higher scores indicating more severe OCD symptoms. Patients are defined as responders if they have a score decrease of at least 35% on the Y-BOCS
次要结局
- Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994).(12 months)