Effects of Deep Brain Stimulation (DBS) of the Pedunculopontine Nucleus (PPN) on Gait, Postural Stability, Freezing of Gait (FOG), and Falls
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- STN-PPN Stimulation Effect on Fall Risk
研究概览
简要总结
This is a mechanistic study to determine the differential effects of the dopaminergic and cholinergic systems on attention, gait, and balance. The primary goal of the study is to evaluate the relative effects of pedunculopontine nucleus (PPN) and subthalamic nucleus (STN) Deep Brain Stimulation (DBS) on these features in persons with Parkinson's Disease (PD) who are eligible for DBS for improvement of their motor symptoms and exhibit gait instability with falls. Patients will be enrolled and implanted with bilateral electrodes in one of the approved DBS locations (subthalamic nucleus: STN), but additionally electrodes will be inserted into the experimental target, namely the PPN bilaterally.
详细描述
This is a prospective, single-center randomized controlled trial designed to estimate the potential clinical benefit, and associated risks, of deep brain stimulation of the of the PPN and STN in patients with PD that are candidates for DBS for improvement of their motor symptoms and exhibit gait instability with falls. Patients will be enrolled and implanted with additional bilateral electrodes in the PPN. Each subject will be randomized 1:1 to one of the following sequences: Bilateral STN+PPN stimulation or Bilateral STN stimulation alone. The addition of a bilateral STN stimulation only group allows for the research of potential micro-lesioning effects of the PPN which might affect features of interest even in the absence of PPN stimulation.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Informed consent signed by the subject.
- •Diagnosed with Parkinson's disease per UK Parkinson's Disease Society Brain Bank (Queens Square) criteria for at least 4 years
- •Demonstrates levodopa responsiveness of at least 30%
- •Experiences tremor or motor complications including wearing off and/or dyskinesia
- •DBS candidate per FDA guidelines as outlined in criteria 2-4
- •Candidate for STN targeting per the consensus committee
- •Subject exhibits gait instability, or a history of at least one fall within the last year, or a history of falls on tests of Static or Dynamic Stability.
- •PD Stage 2-3 with predominant axial symptoms or FOG refractory to Levodopa > 600 mg and UPDRS Part III Subscore of >
- •Subject is ambulatory and able to walk for limited periods of time without using an assistive device.
- •18-75 years of age
- •Primary English speaking
- •Physically and cognitively capable of completing evaluations and consent
- •Medically cleared for surgery and anesthesia
- •Female subjects with child-bearing potential have a negative serum pregnancy test prior to DBS surgery
排除标准
- •Exclusion Criteria:
- •Dementia per DSM-V criteria
- •Condition precluding MRI
- •History of supraspinal CNS disease other than PD
- •History of schizophrenia, delusions, or currently uncontrolled visual hallucinations
- •Subjects who require rTMS, ECT, diathermy, or repeat MRI procedures to treat a medical condition.
- •Subjects with a history of seizure disorder
- •Subjects who have made a suicide attempt within the prior year,
- •Subjects with any medical contraindications to undergoing DBS surgery (eg, infection, coagulopathy, or significant cardiac or other medical risk factors for surgery)
- •Subjects with an implanted stimulator such as a cardiac pacemaker, defibrillator, neurostimulator and cochlear implant
- •Subjects who are pregnant or nursing.
- •Patient that is unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
- •Any other reasons that, in the opinion of the investigator, the candidate is determined to be unsuitable for entry into the study.
结局指标
主要结局
STN-PPN Stimulation Effect on Fall Risk
时间窗: 27 months
The purpose of this study is to measure the effect and the mechanism of deep brain stimulation (DBS) of the pedunculopontine nucleus (PPN) on fall risk as established by quantitative gait and balance analysis.
次要结局
- STN-PPN on Attention(27 months)
- STN-PPN on Subjective Measures of Balance in Daily Life(27 months)
- STN-PPN on Linear and Nonlinear Measures of Balance(27 months)
- STN-PPN on Linear and Nonlinear Measures of Gait(27 months)
- STN-PPN on Subjective Measures of Alertness(27 months)
- STN-PPN on Subjective Measures of Sleep(27 months)
- STN-PPN on Subjective Measures of Non-Motor Symptoms(27 months)