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Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease

2026年7月31日 更新者:Jay Alberts、The Cleveland Clinic
The purpose of this study is to learn how brain signals are related to freezing of gait (FOG) and balance problems in Parkinson's disease (PD) and to study how different deep brain stimulation (DBS) settings may affect these symptoms.

研究概览

详细说明

PD is a progressive neurodegenerative disorder characterized by motor symptoms including tremor, rigidity, and bradykinesia. While DBS is an effective treatment for many of these motor symptoms, postural instability and gait dysfunction (PIGD), including FOG, frequently persist and are a major source of falls, loss of independence, and reduced quality of life.

The neural mechanisms underlying PIGD and FOG remain poorly understood, particularly in real-world conditions where these symptoms are most likely to occur. Conventional clinical assessments often fail to reliably provoke these gait disturbances, limiting the ability to study their underlying neurophysiology. At the same time, recent advances in DBS technology - specifically systems capable of recording brain signals, or neural activity - provide a unique opportunity to directly examine brain signals associated with gait impairment.

This study is designed to characterize the neural mechanisms associated with PIGD and FOG in individuals with PD who have an implanted sensing-enabled DBS system (Medtronic Percept™). By integrating neural recordings from the subthalamic nucleus (STN) with detailed biomechanical measurements during walking tasks, the study aims to identify patterns of neural activity that precede, accompany, and follow gait disturbances.

To address the challenge of eliciting ecologically valid gait disturbances, participants will complete walking and balance tasks within a fully immersive virtual reality platform. This system simulates real-world scenarios that are meant to provoke FOG and PIGD, including situations involving environmental constraints, anxiety-inducing contexts, and dual-task cognitive demands.

Additional assessments will include stair ambulation and functional mobility tasks using an instrumented gait platform which provides quantitative measures of temporal, kinematic, and kinetic aspects of walking and balance.

During these tasks, neural activity recorded from the DBS device will be synchronized with motion capture and biomechanical data. This integrated dataset will allow investigators to examine how neural activity relates to gait performance and to identify neural patterns associated with FOG episodes.

Participants will undergo multiple testing sessions under varying DBS conditions, including their clinically optimized DBS therapy and other programmed conditions. These comparisons will enable evaluation of how different stimulation approaches influence neural activity and gait performance.

The knowledge gained from this study is expected to advance understanding of the neural mechanisms underlying gait dysfunction in PD and may inform the development of more personalized and adaptive neuromodulation strategies to better treat these disabling symptoms in the future.

研究类型

介入性

注册 (估计的)

5

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:MacKenzie Dunlap
  • 电话号码:216-219-3949
  • 邮箱:dunlapm4@ccf.org

学习地点

    • Ohio
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic
        • 接触:
        • 首席研究员:
          • Jay L Alberts, PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • You have been diagnosed with Parkinson's disease
  • You already have a deep brain stimulation (DBS) device implanted as part of your medical care - specifically, the Medtronic Percept DBS device
  • Your DBS settings have been stable for at least 3 months
  • You experience freezing of gait (sudden inability to move your feet when trying to walk)
  • You are able to walk on your own for at least 10 minutes without assistance
  • You are willing to temporarily stop your Parkinson's medications and have your DBS settings adjusted for study testing
  • You are able to understand the study and provide consent to participate

Exclusion Criteria:

  • You have a neurological condition other than Parkinson's disease (such as stroke or multiple sclerosis)
  • You have been diagnosed with dementia or have difficulty understanding the study or giving consent
  • You currently have alcohol or substance abuse problems
  • You have hearing or vision problems that would make it difficult to use a virtual reality headset
  • You have any medical or mental health condition that, in the opinion of the study doctor, would make it unsafe or difficult for you to participate

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Participants With Parkinson Disease Undergoing Multi-Condition DBS Assessments

All participants undergo repeated assessments under multiple deep brain stimulation (DBS) conditions in a randomized order. Each participant serves as their own control and completes testing under clinically optimized stimulation, as well as alternative stimulation paradigms. An additional baseline condition without stimulation is performed prior to randomized testing.

Assessments include walking and balance tasks performed in a virtual reality environment designed to simulate real-world gait challenges, as well as stair ambulation and functional mobility tasks. Neural activity is recorded from the implanted DBS device and synchronized with biomechanical and kinematic data collected during task performance. This design enables within-subject comparisons of neural activity and gait performance across stimulation conditions.

Participants have the Medtronic Percept DBS system implanted as part of standard clinical care. During study sessions, stimulation is evaluated under different conditions, including clinically optimized stimulation, off stimulation, and alternative stimulation paradigms. Stimulation settings are temporarily adjusted for research assessments and are returned to clinically optimized settings at the end of each session. Effects of those conditions on task performance are being assessed.
Participants complete walking and balance tasks within a virtual reality environment designed to simulate real-world situations that provoke gait disturbances. Tasks include navigating environmental constraints, performing turning and stopping movements, and completing dual-task cognitive challenges while walking.
Participants complete stair ambulation and functional mobility tasks on an instrumented platform, including ascending and descending steps, walking, turning, and performing dual-task conditions. These assessments provide quantitative measures of gait performance, balance, and functional mobility.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in STN-LFP power fluctuations from single-task walking compared to FOG episode
大体时间:Five sessions completed from enrollment to the end of testing, over an average of one week.
Participants will complete motor, cognitive and dual-task modules in a virtual reality environment that simulates a home-setting, allowing for acquisition of real-world, at-home behavior. They will also complete a stair navigation task under both single and dual-task conditions. During these assessments, neural activity (i.e., subthalamic nucleus local field potentials (STN-LFPs)) will be recorded from the Medtronic Percept Deep Brain Stimulation system. Freezing of gait (FOG) episodes will be marked by a clinician, and change in STN-LFP power fluctuations from single-task walking compared to FOG episodes will be analyzed as the primary outcome.
Five sessions completed from enrollment to the end of testing, over an average of one week.

次要结果测量

结果测量
措施说明
大体时间
Number of FOG episodes during the MOVE system modules under each of the four DBS conditions
大体时间:Five sessions completed from enrollment to the end of testing, over an average of one week.
Participants will complete motor, cognitive and dual-task modules in a virtual reality setting, Moving Overground in Virtual Environments (MOVE). The MOVE system simulates a home-setting, allowing for acquisition of real-world, at-home behavior. It consists of four modules: 1) Reference, 2) Physical, 3) Anxiety, 4) Cognitive (dual-task). Freezing of gait (FOG) episodes usually occur under stressful circumstances which can be grouped into three broad categories: changes in physical environment, anxiety-provoking situations and dual-task environments. The modules in the MOVE system are designed to elicit FOG episodes in a research setting. FOG episodes will be marked by a clinician, and the number of episodes under each of the four DBS conditions will be compared.
Five sessions completed from enrollment to the end of testing, over an average of one week.
Overall time for SAFE-Gait task
大体时间:Five sessions completed from enrollment to the end of testing, over an average of one week.
Participants will complete the Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait). The SAFE-Gait test requires participants to 1) ascend 3 standard steps, 2) walk on a flat surface for 3 meters, 3) turn and 4) walk back to the starting position which requires descending 3 steps. The time to complete this task will be recorded and compared for all tested DBS conditions.
Five sessions completed from enrollment to the end of testing, over an average of one week.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Jay L Alberts, PhD、The Cleveland Clinic

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月18日

初级完成 (估计的)

2027年3月18日

研究完成 (估计的)

2027年4月18日

研究注册日期

首次提交

2026年7月27日

首先提交符合 QC 标准的

2026年7月31日

首次发布 (实际的)

2026年8月6日

研究记录更新

最后更新发布 (实际的)

2026年8月6日

上次提交的符合 QC 标准的更新

2026年7月31日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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