Refining the Target for Deep Brain Stimulation (DBS) in Severe, Treatment Refractory Obsessive Compulsive Disorder (OCD)
试验速览
- 阶段
- 1 期
- 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
In select, therapy resistent patients with Obsessive Compulsive Disorder (OCD) Deep Brain Stimulation (DBS) has been used as a treatment. DBS is a therapy modality in which electrodes are implanted within specific sub-structures of the brain in order to modulate the activity in targeted neural circuits associated with different neurological disorders. The results of this novel approach to psychiatric disorders have been optimistic. This study aims to investigate wether or not the distance to target location has an influence on the outcome.
In order to deliver DBS, leads containing four electrodes are implanted into the brain target in the ventral capsule/ventral striatum (VC/VS). After an optimization period, patients enter a triple blind randomised two fazed crossover design of two periods of three months. In both crossover branches, patients, evaluating psychiatrist and psychologist are blinded for the stimulation conditions. These conditions are stimulation ON (at optimal parameters) and stimulation OFF. Stimulation parameters are constant during the entire period. During the second crossover branch, stimulation conditions are reversed for all patients.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD (300.3).
- •Failure of documented trials of pharmacotherapy, following an appropriate treatment algorithm for OCD.
- •Failure of documented trial of cognitive and behavioural therapy
- •Duration of illness: min. 5 year
- •Y-BOCS at least 30/
- •Age: 20-65 year
排除标准
- •DSM-IV diagnosis on axis 2 of severe personality disorder in cluster A or B, especially in the case of heightened risk for acting-out behavior.
- •DSM-IV diagnosis on axis 3 of organic brain pathology or significant abnormalities on MRI.
- •Present or past history of psychotic symptoms.
- •Present substance abuse, or instable remission of substance abuses (i.e. no substance abuse during the last 12 months).
- •Any disorder affecting cognitive functioning, other than motor tics and Gilles de la Tourette's Syndrome
- •Mental retardation. A minimum threshold of cognitive skills is needed for adequate reporting on questionnaires and evaluation, and for technical handling of the instruments in a later faze.
- •The patient must be juridical free.
研究组 & 干预措施
VC/VS stimulation ON followed by OFF
triple blind, randomised, two periods of three months
干预措施: VC/VS stimulation (Device)
VC/VS stimulation OFF followed by ON
triple blind, randomised, two periods of three months
干预措施: VC/VS stimulation (Device)
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale (Y-BOCS)
时间窗: up to 12 months
次要结局
- Beck depression inventory(up to 12 months)
- Inventory of Depressive Symptoms (IDS)(up to 12 months)
- Patient Global Impression (PGI).(up to 12 months)
- Global assessment of functioning (GAF)(up to 12 months)
- Hamilton scale for anxiety(up to 12 months)
- Quality of Life and Satisfaction Questionnaire (Q-Les-Q)(up to 12 months)
- Clinical Global Impression (CGI)(up to 12 months)
- Symptom Checklist (SCL-90)(up to 12 months)