The Effect of Low Frequency STN DBS on Sleep and Vigilance in PD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Differences in sleep efficiency between the high and low frequency nights
研究概览
简要总结
The study design is a within-subject randomized cross-over design to evaluate the effects of DBS on sleep architecture, as measured by polysomnography, and on wake-time vigilance, as measured by a virtual reality street-crossing simulator.
详细描述
In the proposed study, we will use a within-subject randomized clinical trial to measure objective changes in sleep architecture with DBS "on" and to compare effects of different DBS stimulation parameters on sleep architecture as measured by sleep studies. The study design will allow us to address our hypothesis that low frequency deep brain stimulation parameters are more effective than the conventional settings at improving sleep architecture and wake-time vigilance. If our hypothesis is correct, low frequency settings could be used during sleep and this would prolong stimulator battery life, therefore decreasing the frequency of required surgical battery changes for DBS. These data will be valuable in considering clinical treatment strategies and provide insight into the basic mechanisms of sleep dysfunction in PD. The study may also contribute to understanding how to achieve maximum clinical benefit from DBS while minimizing morbidity and cost.
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
- Double (Participant, Investigator)
盲法说明
Participant was blinded to the DBS settings during the sleep study but investigator was not; however, the investigator was blinded to the DBS setting during the interpretation of the sleep study.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have undergone bilateral subthalamic nucleus (STN) DBS surgery for treatment of PD.
- •Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies.
- •Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score >5)
- •19 years of age or older
- •Ability to walk up and down stairs
排除标准
- •Known narcolepsy
- •Other previous surgical treatment of Parkinson's disease(with the exception of unilateral STN DBS) including pallidotomy, thalamotomy, or gene therapy procedures.
- •Pregnant women will be excluded from this study.
- •Untreated obstructive sleep apnea. If obstructive sleep apnea is discovered during the first sleep study, the subject will be removed from the study. After they have been treated for at least 6 weeks with continuous positive airway pressure (CPAP), they can re-start the study.
- •Inability to walk without assistance, including a cane, wheelchair, or walker
- •Cognitive dysfunction that would prevent subject's ability to participate in the study.
结局指标
主要结局
Differences in sleep efficiency between the high and low frequency nights
时间窗: 3 non-consecutive nights of sleep study within 4 weeks
Phase I subjects will undergo 2 sleep studies, one with the stimulator "on" at the subject's stable, clinically effective settings and one with the stimulator "off." Phase 2 subjects will spend the first night in the sleep lab with DBS turned off. The order of the high and low frequency nights (on the second and third study nights) will be randomized.
次要结局
- Wake-time vigilance as measured by a virtual reality street-crossing simulator(4 weeks)
研究者
Amy Amara, MD
Assistant Professor
University of Alabama at Birmingham