跳至主要内容
临床试验/NCT05557864
NCT05557864招募中不适用

Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinson's Disease; Udall Project 2 Aims 1 & 2

University of Minnesota1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年8月25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
24
试验地点
1
主要终点
Changes in the combined elastic, viscous and inertial resistance across conditions will be assessed by integrating the resistive torque

研究概览

简要总结

This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson's disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to these medically intractable symptoms.

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
21 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of idiopathic PD
  • have undergone neurosurgery to implant deep brain stimulators in the globus pallidus (GP DBS) or subthalamic nucleus (STN)
  • Existing 7T brain imagery

排除标准

  • history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
  • other significant neurological disorder
  • history of dementia or cognitive impairment as found with UBACC (or MacCAT-CR)
  • post-operative complications or adverse effects

研究组 & 干预措施

Parkinson's disease with DBS

Experimental

Participants will have a diagnosis of idiopathic PD and have undergone/will undergo neurosurgery to implant deep brain stimulators in the globus pallidus (GP DBS) or subthalamic nucleus (STN)

干预措施: Deep Brain Stimulation (Device)

结局指标

主要结局

Changes in the combined elastic, viscous and inertial resistance across conditions will be assessed by integrating the resistive torque

时间窗: 3 weeks

Average movement rate and amplitude for each tone rate-movement amplitude interval. The amount of variability in angular displacement and velocity will be calculated using the root mean square of the zero mean signal. The structure of the variability will be calculated using the sample entropy function. In addition, we will quantify the number and duration of movement festination or freezing episodes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Colum MacKinnon

Principal Investigator

University of Minnesota

研究点 (1)

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