ENGAGE-PD: Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Stride Time Coefficient of Variation
研究概览
简要总结
The purpose of this study is to assess how alternating-frequency Deep Brain Stimulation (DBS) works to improve postural instability and gait, while also treating other motor symptoms of Parkinson Disease (PD).
详细描述
Postural instability, gait impairment, and falls are among the greatest unmet needs in Parkinson disease (PD). A single fall can be catastrophic, and impairments that limit mobility lead to social isolation or depression, and adversely affect bone and cardiovascular health. Unfortunately, postural instability and gait disorders are refractory to current pharmacological and surgical treatments, including deep brain stimulation (DBS). This project will directly address this pressing need. We will recruit participants to perform a gait task, using a new, alternating DBS frequency paradigm, while body movements and neural signals are recorded. The findings will lead to improved therapies to address these symptoms in the future.
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
盲法说明
There is only one arm in the study. Participants will be masked to which device intervention is active, but they will not be masked to the medication state.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral STN DBS for PD
- •Medtronic Percept PC implanted DBS battery/pulse generator/recording system
- •Presence of balance and/or walking impairment and/or freezing of gait
- •Can walk without assistance, OFF meds, based on yes/no verbal response
排除标准
- •Severity of gait impairment should not require dependency to walker or cane
- •Cannot tolerate monopolar stimulation at either of the two middle electrode contacts (prerequisite for the recording mode of the DBS) at high frequency (130 Hz) or low frequency (60 Hz).
- •Concomitant conditions that may affect significantly the evaluation of balance or gait, including orthopedic, rheumatologic or other neurological diseases
- •Contraindication to physical therapy
- •Age < 21
- •Diagnosis of dementia
- •Not agreeable to having video taken of entire research visit
研究组 & 干预措施
Alternating-Frequency DBS
In this single-arm study, all participants will receive all interventions in a crossover fashion.
干预措施: High-Frequency-Only Stimulation (Device)
Alternating-Frequency DBS
In this single-arm study, all participants will receive all interventions in a crossover fashion.
干预措施: Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation (Device)
Alternating-Frequency DBS
In this single-arm study, all participants will receive all interventions in a crossover fashion.
干预措施: Low-Frequency-Only Stimulation (Device)
Alternating-Frequency DBS
In this single-arm study, all participants will receive all interventions in a crossover fashion.
干预措施: ON Dopaminergic Medication (Drug)
Alternating-Frequency DBS
In this single-arm study, all participants will receive all interventions in a crossover fashion.
干预措施: Alternating, 50 sec High-Frequency, 50 sec Low-Frequency Stimulation (Device)
Alternating-Frequency DBS
In this single-arm study, all participants will receive all interventions in a crossover fashion.
干预措施: Alternating, 10 sec High-Frequency, 50 sec Low-Frequency Stimulation (Device)
Alternating-Frequency DBS
In this single-arm study, all participants will receive all interventions in a crossover fashion.
干预措施: Alternating, 50 sec High-Frequency, 10 sec Low-Frequency Stimulation (Device)
Alternating-Frequency DBS
In this single-arm study, all participants will receive all interventions in a crossover fashion.
干预措施: OFF Dopaminergic Medication (Drug)
结局指标
主要结局
Stride Time Coefficient of Variation
时间窗: During the intervention
Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors.
Tremor Amplitude
时间窗: During the intervention
Marker of tremor severity, derived from kinematic recordings from body-worn wireless sensors.
Percentage of Time with Tremor Present
时间窗: During the intervention
Marker of tremor severity, derived from kinematic recordings from body-worn wireless sensors.
次要结局
- Gait Velocity(During the intervention)
- Step Cadence(During the intervention)
- LFP and EEG power spectrum correlation with behavior and kinematics(During the intervention)
- LFP and EEG connectivity correlation with behavior and kinematics(During the intervention)
- Total Freezing Time(During the intervention)
- Freezing Index(During the intervention)
研究者
James Liao
Principal Investigator
The Cleveland Clinic