Neurofeedback of Activity in the Orbitofrontal Cortex for OCD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms
研究概览
简要总结
The aim of this study is to train patients with obsessive-compulsive disorder to control a region of their brain that has been associated with their symptoms. Patients in the experimental group will be given direct feedback regarding activity in this brain area while they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to learn to control activity in the region during these feedback sessions. A separate group of patients will be given a control form of feedback that we do not believe can have clinical benefits. Our primary hypothesis is that the neurofeedback training will reduce OCD symptoms more than the control feedback.
详细描述
Original study design recruiting controls who were matched to the experimental group was changed to a randomized design prior to enrollment of the first participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Primary Diagnosis of Current OCD, based on Diagnostic and Statistical Manual (DSM-IV) criteria, a Y-BOCS (Yale-Brown Obsessive-Compulsive Scale) score >=16
- •Principle OCD symptoms- Primary symptoms must be either Cleaning/Contamination or Checking; other symptoms okay
- •Unmedicated (or medications stable for 8 weeks).
- •Research group must be able to identify a target region in the orbitofrontal cortex that is related to symptoms
排除标准
- •Active Psychosis; Pervasive Developmental Disorder ; epilepsy or other major neurological disorder
- •History of major head trauma or psychosurgery
- •Active Substance Abuse within 6 months
- •Seizure disorder or other significant neurological disorder
- •Active Suicidality
- •Pregnancy
- •severe claustrophobia, ferromagnetic metal in the body, a pacemaker or defibrillator, or any other condition that would make MRI scanning unsafe or inappropriate
- •any psychotropic medication other than a selective serotonin reuptake inhibitor (SSRI) antidepressant, anafranil, or a low-dose hypnotic or anxiolytic taken on an as-needed basis
- •active cognitive/behavioral therapy initiated within the last 3 months (continuation of established maintenance therapy that has been going on for longer than 3 months will not be grounds for exclusion)
研究组 & 干预措施
neurofeedback
Two imaging sessions of neurofeedback.
干预措施: neurofeedback (Behavioral)
control feedback
Two imaging sessions of feedback
干预措施: control feedback (Behavioral)
结局指标
主要结局
A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms
时间窗: Approximately 4 days post-intervention
A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms
时间窗: Immediately before intervention
次要结局
- Control over target brain area(Approximately 4 days pre-intervention)
- Control over the target brain area.(Approximately 4 days post-intervention)