Cerebral Metabolic Changes Associated With Thalamic Stimulation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Areas of the brain with low activity
研究概览
简要总结
The purpose of this research study is to evaluate the brain circuits function and circuits involved in the mechanism of thalamic DBS in patients with medically refractory epilepsy.
详细描述
Deep brain stimulation (DBS) of the anterior nucleus of the thalamus in patients with medically refractory epilepsy has been shown to be efficacious. Studies have estimated a 46-76% reduction in seizures relative to the baseline. However, the exact anatomic circuitry involved in the mechanism of DBS in epilepsy remains unknown. Positron emission tomography (PET) studies can provide clues to the metabolic activity associated with DBS activation. In our study, patients will be scanned with their DBS electrodes turned "on" and "off". PET data captured during these two distinct states may show characteristic differences in cerebral glucose metabolism and modulatory effects of surrounding cerebral structures, thus providing clues to how DBS works to prevent seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-85 years old
- •currently have DBS implanted for medically refractory epilepsy
- •Women of childbearing age will be required to use established contraceptive methods while enrolled in the study.
排除标准
- •Patients who:
- •are < 18 years of age or > 85 years of age
- •are medically unstable
- •are women who are potentially pregnant, pregnant or nursing
- •have had PET imaging within 1 year.
结局指标
主要结局
Areas of the brain with low activity
时间窗: within 30 days of enrollment in the study
This measure will be based on the results of two PET scans done on separate days. The stimulator will be "on" during the first PET image acquisition and "off" during the second PET image acquisition.
次要结局
- Brain Abnormalities(within 30 days of enrollment in the study)
- Ability to learn and understand(within 30 days of enrollment in the study)
研究者
Elysa Widjaja
Staff Neuroradiologist
The Hospital for Sick Children