Repetitive Transcranial Magnetic Stimulation (rTMS) for Obsessive-Compulsive Disorder (OCD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Response
研究概览
简要总结
The study aims to assess the impact of repetitive transcranial magnetic stimulation (rTMS) on brain imaging and neurophysiological measures of cognitive control in patients with Obsessive-Compulsive Disorder (OCD).
详细描述
With a prevalence of nearly 3%, obsessive-compulsive disorder (OCD) is one of the most common psychiatric disorders in the US. The first line of treatment for OCD comprises pharmacotherapy with serotonin reuptake inhibitors (SRIs) and cognitive behavioral therapy (CBT). Although adherence to these therapies has been shown to improve symptoms in at least half of patients, some have residual symptoms and a small percentage are refractory to standard therapies. Transcranial magnetic stimulation (TMS) may offer an alternate, less-invasive therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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 Obsessive Compulsive Disorder, as confirmed by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) (SCID).
- •Subjects should have at least a moderate level of OCD severity as defined by a Yale-Brown Obsessive Compulsive Disorder Scale (YBOCS) score of ≥ 20.
排除标准
- •Individuals diagnosed by the investigators with the following conditions: Bipolar Disorder (lifetime), any Psychotic Disorder (lifetime), history of substance abuse or dependence within the past year (expect nicotine and caffeine).
- •An Axis II Personality Disorder, which in the judgment of the investigator may hinder the patient in completing the procedures required by the study protocol.
- •Individuals with a clinically defined neurological disorder including, but not limited to: stroke, tics, space occupying brain lesion, any history of seizures except those therapeutically induced by electroconvulsive therapy (ECT), history of cerebrovascular accident, transient ischemic attack within two years, cerebral aneurysm, dementia, Parkinson's Disease, Huntington Chorea, Multiple Sclerosis.
- •Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for >5 minutes.
- •History of treatment with rTMS therapy for any disorder.
- •History of treatment with Deep Brain Stimulation.
- •Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
- •Intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
- •Current illicit drug use.
结局指标
主要结局
Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Response
时间窗: Up to 1 month
Change in blood-oxygen-level dependent (BOLD) correlates corresponding to task engagement before and after rTMS will be assessed.
次要结局
未报告次要终点