NCT04116996招募中不适用
Stimulation of the External Pallidal Segment for Insomnia in Patients With Parkinson's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Insomnia Severity Index
研究概览
简要总结
Researchers are to determine if turning on an additional unilateral DBS (deep brain stimulation) electrode with stimulation to the globus pallidus externa (GPe) region of the brain will improve insomnia (sleep).
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-80 years of age
- •Symptomatic with Parkinsonism for 7-20 years
- •Severe insomnia based on ISI score
排除标准
- •Clinically significant dementia (MMSE <23)
- •Hoehn & Yahr [Hoehn, 1967 #1839] stage I or V disease
- •Other significant neurological or psychiatric disease
- •Previous pallidotomy or thalamotomy
- •Previous placement of other implantable devices
- •Secondary parkinsonism (non-idiopathic parkinsonism)
- •Inability to travel to Jacksonville for post-operative study visits
- •Severe sleep apnea
- •Insomnia due to pain or untreated mood disorder
- •Contraindications to 3T MRI
- •Circadian rhythm sleep disorders.
- •Current use of hypnotics
结局指标
主要结局
Change in Insomnia Severity Index
时间窗: 3 and 6 months
Change in self-reported insomnia severity index questionnaire score, using a total score scale of 0-7 is no clinically significant insomnia, 8-14 is subthreshold insomnia, 15-21 is clinical insomnia (moderate severity), 22-28 is Clinical insomnia (severe)
次要结局
- Change in Parkinson's Sleep Scale (PDSS)(3 and 6 months)
研究者
Pablo Castillo
Principal Investigator
Mayo Clinic
研究点 (2)
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