Deep Brain Stimulation (DBS) of the Ventral Capsule/Ventral Striatum (VC/VS) for the Treatment of Refractory Obsessive-compulsive Disorder (OCD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Quality of Life as measured by the Short-Form 36
研究概览
简要总结
Deep brain stimulation for treatment resistant deep brain stimulation
详细描述
Subjects will receive bilateral deep brain stimulation to the ventral capsule/ventral striatum. They will receive standard follow-up and device programming over the span of 52 weeks. After that, they will enter a 5 week double blinded crossover phase consisting of 2 weeks of ON or OFF stimulation, separated by 1 week of 'washout', during which stimulation will be OFF.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
An independent member of the study team will perform the randomization and programming, allow for care givers, participants, investigator, and outcomes assessors to be blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or Male patients between age 18-70
- •DSM-V diagnosis of Obsessive Compulsive Disorder (OCD), at least 5-year illness history with a minimum score of 24 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
- •Medication-refractoriness as determined by an adequate dose and duration of psychiatric treatments (including psychotherapy and/or pharmacology) as determined by two psychiatrists associated with the study. Including specifically:
- •Failed adequate trial of two or more medications accepted as first line in the treatment of OCD
- •Attempted augmentation, if tolerated, by at least 1 medications known to be first line treatments for OCD
- •An adequate trial of cognitive behavioural therapy
- •Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols
排除标准
- •Any past or current evidence of psychosis or mania (patients with co-morbid depression will not be excluded from the study)
- •Active neurologic disease, such as epilepsy
- •Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
- •Current suicidal ideation
- •Any contraindication to MRI scanning
- •No contraindication for DBS surgery
- •Presence of significant cognitive impairment
- •Likely to relocate or move out of the country during the study's duration
- •Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure.
- •Currently pregnant (as determined by history and serum HCG) or lactating; for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
结局指标
主要结局
Quality of Life as measured by the Short-Form 36
时间窗: 12 months compared to baseline
Measured by the short form 36 (SF-36). The scores range from 0-100 with lower numbers indicating a worse quality of life.
次要结局
- Obsessive compulsive symptoms as measured by the Yale-Brown Obsessive Compulsive Scale during randomization(Recorded at the end of the 2 week ON and OFF stimulation periods, which occur immediately after the 52 week open-label period)
- Obsessive compulsive symptoms as measured by the Yale-Brown Obsessive Compulsive Scale(12 months)
研究者
Dr. Nir Lipsman
Dr Nir Lipsman, MD, PhD, Neurosurgeon, Scientist
Sunnybrook Health Sciences Centre