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临床试验/NCT06994728
NCT06994728招募中不适用

Characterization of Subthalamic Nucleus Deep Brain Stimulation Laterality on Visuospatial Attention and Correlation to Freezing of Gait in Parkinson's Disease

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年4月1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
12
试验地点
1
主要终点
Characterize the individual impact of lateralized STN DBS stimulation on freezing of gait in Parkinson's disease

研究概览

简要总结

The purpose of this research is to determine how deep brain stimulation (DBS) for Parkinson's disease affects attention and visuospatial function. Additionally, this study will evaluate how deficits in visual attention are associated with freezing of gait (FOG) in Parkinson's disease. There is currently no reliable treatment for FOG and little is understood about the underlying reason this occurs. Some recent research has found that stimulating the right side of the brain seems to improve FOG. The right side of the brain is also paramount for visual attention, which is why investigators are conducting this study.

详细描述

FOG is a common and frequently disabling symptom of PD, affecting more than half of all PwPD. It remains a complex and incompletely understood phenomenon, with no currently approved therapies. FOG is often exacerbated during dual-tasks where attention is divided to multiple tasks. A well known method of provoking FOG by PwPD and neurologists alike is to walk through doorways or through a crowded space, regions where spatial attention is necessary. Similarly, significant visuospatial attention deficits have been found in PwPD who freeze compared to those do not. Further evidence demonstrates that the STN is part of the circuit which modulates spatial attention, and that STN-DBS has a significant impact on visuospatial attention and is notably improved with right sided stimulation. Indeed, visuospatial attention is largely considered to be predominantly lateralized to the right hemisphere. Interestingly, one study showed that right STN-DBS stimulation affecting a volume of activated tissue (VAT) connected to the right sensorimotor cortex showed a significant association with reduction in FOG. The impact of STN-DBS on visuospatial attention and the degree to which this change in attention is associated with changes in FOG has not yet been studied, and may well explain part of the pathophysiology of FOG and how to treat PwPD who freeze. The present study will build on the aforementioned research by prospectively evaluating the impact of lateralized STN-DBS stimulation on visuospatial attention in PwPD, and correlating this with change in FOG.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Investigator will not be blinded as they will need to make adjustments to patient deep brain stimulation settings during testing.

入排标准

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

入选标准

  • •Subjects above 18 years of age
  • •Subjects with freezing of gait
  • •Subjects with bilateral STN-DBS surgery as part of their clinical care for Parkinson's disease

排除标准

  • •Uncorrected visual or hearing impairments, as indicated by self-report
  • •Individuals who are pregnant or expect to become pregnant during the course of the study
  • •Individuals with dementia or relevant brain lesions impacting cognition or gait

研究组 & 干预措施

Left STN-DBS on, right STN-DBS off first

Active Comparator

STN-DBS will be turned off sequentially for each side, in this group beginning with left STN-DBS on and right STN-DBS off. This will then be followed by the corollary.

干预措施: Left STN-DBS on, right STN-DBS off first (Device)

Right STN-DBS on, left STN-DBS off first

Active Comparator

STN-DBS will be turned off sequentially for each side, in this group beginning with right STN-DBS on and left STN-DBS off. This will then be followed by the corollary.

干预措施: Right STN-DBS on, left STN-DBS off first (Device)

结局指标

主要结局

Characterize the individual impact of lateralized STN DBS stimulation on freezing of gait in Parkinson's disease

时间窗: 1 hour

Investigators hypothesize that right STN stimulation will have a significant association with reduction in freezing of gait, as measured by timed up and go task, compared to left STN stimulation and no stimulation.

Determine if there is a correlation between the change in visuospatial function due to lateralized STN DBS stimulation and change in freezing of gait (FOG) in Parkinson's disease

时间窗: 1 hour

Investigators hypothesize that right STN stimulation induced improvement in attention will be associated with improvement in FOG.

次要结局

  • Determine if there is a correlation between the change in Flanker task due to lateralized STN DBS stimulation in Parkinson's disease(30 minutes)
  • Determine if there is a correlation between the change in Go-No-Go task due to lateralized STN DBS stimulation in Parkinson's disease(30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nathan DeTurk

Medical/Dental Resident

Medical University of South Carolina

研究点 (1)

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