Evaluating Unilateral Deep Brain Stimulation (DBS) of the Bed Nucleus of the Stria Terminalis (BNST) in Patients With Obsessive Compulsive Disorder (OCD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Visual analogue scale (VAS) ratings of mood and anxiety/stress
研究概览
简要总结
The investigators previously showed that deep brain stimulation (DBS) in the bed nucleus of the stria terminalis (BNST) reduces symptoms in patients with severe obsessive-compulsive disorder (OCD). Although most patients now receive bilateral stimulation, multiple studies suggest that stimulation of the left BNST might be equally effective.
In this study, the investigators will evaluate the effect of unilateral stimulation in OCD patients who currently receive bilateral BNST stimulation to treat their symptoms. We hypothesize that unilateral stimulation of the left BNST will reduce anxious and depressive symptoms, compared to no stimulation.
The study entails a double-blinded, randomized cross-over design during which every patient undergoes four stimulation conditions: stimulation of the left, right or bilateral BNST, or no stimulation. During every condition, which takes about fifteen minutes, the patient is exposed to an individually determined stimulus that normally elicits OCD-related symptoms. The patients are then asked to fill out a short questionnaire to evaluate the severity of their symptoms during the four conditions. At the end of the cross-over phase, the stimulation parameters of each patient are restored.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Both the patient and the psychiatrist are blinded during the cross-over phase, until the end of the study. The investigator who will evaluate behavior from the videorecordings, will also be blinded.
Unblinded are: the principal investigator (who has access to all data) and the technical staff in charge of stimulation settings.
入排标准
- 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
研究组 & 干预措施
Stimulation of bilateral BNST
干预措施: Electrical stimulation of the BNST (Device)
Stimulation OFF
干预措施: Electrical stimulation of the BNST (Device)
Stimulation of left BNST
干预措施: Electrical stimulation of the BNST (Device)
Stimulation of right BNST
干预措施: Electrical stimulation of the BNST (Device)
结局指标
主要结局
Visual analogue scale (VAS) ratings of mood and anxiety/stress
时间窗: After 15 minutes of stimulation
For every question on the VAS, there will be a line of 10 centimeters as an outcome measure. The patient will place a mark on this line, in correspondence to their symptoms. The minimum is 0%, which corresponds to no symptoms at all. The maximum is 100% (marker at the end of the 10 centimeter line), and indicates the most severe symptoms. Every millimiter that the mark is removed from the left boundary of the line, is considered as 1%. Measurements of mood and anxiety/stress will be scored using 2 VAS scales. We will only look at sub score, not total scores. A higher score corresponds to more severe symptoms. By using a continuous line as an outcome rather than fixed numbers (1-2-3-...), our rating is far more sensitive to small deviations in how symptoms are experienced.
次要结局
- VAS ratings of obsessive thoughts, urge to perform compulsive behavior, avoidance and global wellbeing(After 15 minutes of stimulation)