Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in STN-LFP power fluctuations from single-task walking compared to FOG episode
研究概览
简要总结
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.
详细描述
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.
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
- None
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
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Multiple Deep Brain Stimulation (DBS) Conditions (Other)
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.
干预措施: Moving Overground in a Virtual Environment (MOVE) (Behavioral)
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.
干预措施: Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait) (Behavioral)
结局指标
主要结局
Change in STN-LFP power fluctuations from single-task walking compared to FOG episode
时间窗: 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.
次要结局
- Number of FOG episodes during the MOVE system modules under each of the four DBS conditions(Five sessions completed from enrollment to the end of testing, over an average of one week.)
- Overall time for SAFE-Gait task(Five sessions completed from enrollment to the end of testing, over an average of one week.)