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临床试验/NCT05962489
NCT05962489招募中不适用

Sleep-specific DBS Therapy in Parkinson's Disease

University of Minnesota1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年6月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
64
试验地点
1
主要终点
Actigraphy

研究概览

简要总结

Sleep-wake disturbances are a major factor associated with reduced quality of life of individuals with Parkinson's disease (PD), a progressive neurological disorder affecting millions of people in the U.S and worldwide. The brain mechanisms underlying these sleep disorders, and the effects of therapeutic interventions such as deep brain stimulation on sleep-related neuronal activity and sleep behavior, are not well understood. Results from this study will provide a better understanding of the brain circuitry involved in disordered sleep in PD and inform the development of targeted therapeutic interventions to treat sleep disorders in people with neurodegenerative disease.

详细描述

Sleep-wake disturbances are a major factor associated with reduced quality of life of individuals with Parkinson's disease (PD), a progressive neurological disorder affecting millions of people in the U.S and worldwide. This study will examine the sleep of people who are receiving Deep Brain Stimulation (DBS) therapy for PD. DBS uses electrical fields to change the activity in a few structures deep in the brain, to improve motor (movement) symptoms of Parkinson's disease (PD). The DBS system includes a wire (the lead) that goes deep in the brain to deliver electricity and a battery pack (IPG) that controls the electricity that is delivered by the lead. Patients receiving this treatment may have a lead implanted on just one side of their brain (unilateral) or both sides (bilateral).

In this proposal, we will recruit people who have DBS systems with the electrical lead implanted in the internal segment of the globus pallidus (GPi) or the subthalamic nucleus (STN). The GPi and STN are two parts of the brain that are commonly targeted in DBS therapy to treat PD symptoms. The site of lead implantation (GPi or STN) will be decided by their clinical team, as is standard-of-care. Participation in this study will have no impact on site selection (and in fact, site selection will take place before recruitment and enrollment in this study).

There are two separate studies in this proposal: an Aims 1 & 2 study, and an Aim 3 study.

All participants will be 21 years or older. All participants in Aims 1 & 2 may potentially be recruited for Aim 3, however enrollment in Aim 3 is not contingent upon enrollment in Aims 1 & 2.

Participants in both studies will have received a 7 Tesla MRI scan (either as part of their regular clinical treatment, or as part of a different study, run by Dr. Noam Harel), which is a very detailed image of the brain. Participants will be asked for their permission to use these images as research data for these studies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of idiopathic PD
  • At least 21 years old
  • Existing or planned 7T brain imaging
  • Surgery at UMN to implant DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care
  • Surgery at UMN to implant bilateral DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care (or has already occurred, as long as the initial programming session is at least 2 weeks away)

排除标准

  • Other significant neurological disorder
  • History of dementia
  • Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
  • Pregnant women
  • Known radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy to place ECoG strip

研究组 & 干预措施

OFF DBS followed by ON DBS

Experimental

干预措施: Clinically optimized deep brain stimulation (Other)

ON DBS followed by OFF DBS

Experimental

干预措施: Clinically optimized deep brain stimulation (Other)

结局指标

主要结局

Actigraphy

时间窗: 12 months post DBS surgery

Actigraphy-based measures of sleep quality

pallidopeduncular and pedunculopallidal pathway activation

时间窗: 12 months post DBS surgery

Percent of pallidopeduncular and pedunculopallidal pathway activation

Clinical Rating Scales

时间窗: 12 months post DBS surgery

Total scores from the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale

GPe activation

时间窗: 12 months post DBS surgery

percent of GPe activation

pallidopeduncular and pedunculopallidal pathway activation

时间窗: 6 months post DBS surgery

Percent of pallidopeduncular and pedunculopallidal pathway activation

GPe activation

时间窗: 6 months post DBS surgery

percent of GPe activation

Actigraphy

时间窗: 6 months post DBS surgery

Actigraphy-based measures of sleep quality

Clinical Rating Scales

时间窗: 6 months post DBS surgery

Total scores from the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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