An Integrated Biomarker Approach to Personalized, Adaptive Deep Brain Stimulation in Parkinson Disease [Formerly: Scalar Closed-Loop STN/GPi DBS Based on Evoked and Spontaneous Potentials (Permanently Implanted Medtronic RC+S Studies)]
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 48 months after IPG implant.
研究概览
简要总结
This study involves patients who are already planning to have deep brain stimulation (DBS) surgery to treat the symptoms of severe Parkinson's Disease (PD). The study has two goals:
- to evaluate the effectiveness of implanting DBS electrodes in the two most common locations for DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)), instead of just one electrode, on each side of the brain; and
- to develop an adaptive DBS system using brain signals measured from these two electrodes.
详细描述
The purpose of this study is a small, first in man, clinical feasibility trial for patients with severe Parkinson's Disease (PD), who are already clinically eligible for deep brain stimulation (DBS) with two goals:
- to compare efficacy from two common sites of DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)) through the implantation of dual DBS electrodes on each side of the brain; and
- to develop a closed loop DBS system using evoked and spontaneous potentials derived from these two electrodes.
The study will involve bilateral dual DBS electrode placement in clinically standard locations (ie, STN and GPi) unilaterally or (more often) bilaterally, the placement of the RC+S Medtronic research implantable pulse generator (IPG), and a commitment to return for both extensive postoperative programming and testing to define clinical efficacy and separate research days to develop the closed loop approach. In addition, patients will undergo intraoperative research using temporary percutaneous extensions to the DBS electrode(s) and DBS lead cannula after implantation to confirm the electrode location and to identify what the signals will look like during later chronic recordings through the research IPG.
The research RC+S IPG includes both ordinary DBS stimulation as well as a recording system that simultaneously measures the DBS local evoked potential (DLEP) and/or local field potential (LFP) responses from either the same or a second DBS electrode.
In a separate cohort, we are enrolling healthy volunteers as blinded raters of audio recordings made by people with Parkinson's disease and without Parkinson's disease to study whether different features of speech patterns are specific to PD and whether there are measurable differences in these speech features when PD participants are on different deep brain stimulation settings. These ratings do not contribute to the primary or secondary endpoints of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Implanted RC+S arm Inclusion /
排除标准
- •Inclusion Criteria:
- •able to give informed consent
- •diagnosed with Parkinson's Disease and is considered a surgical candidate for DBS
- •has medication-related side effects from levodopa (i.e., dyskinesias, on-off fluctuations)
- •has off-on improvement with levodopa of at least 30%
- •is available for follow-up visits for length of study
- •Exclusion Criteria:
- •is not safe surgical candidate for DBS
- •has severe neurological injury or disease other than Parkinson's Disease
- •has condition requiring repeated MRI scans
- •has untreated, clinically significant depression
- •has an electrical or electromagnetic implant
- •had a prior thalamotomy or surgical ablation procedure
- •has dementia interfering with ability to comply with study requirements or give informed consent
- •abuses drugs or alcohol
- •has a history of seizures
- •has any metallic implants
- •is pregnant
- •Speech Rater Inclusion / Exclusion Criteria:
- •Inclusion Criteria:
- •able to give informed consent
- •has no hearing impairment (by self-report)
- •is a native English speaker
- •Exclusion Criteria:
- •is a speech therapist or clinician in a related field
- •studies linguistics / logopedics
研究组 & 干预措施
Implanted RC+S
Implanted Medtronic RC+S IPG with dual DBS electrodes in STN and GPi. DBS stimulation will be administered to: 1) STN alone, 2) GPi alone, 3) cooperative STN + GPi, and 4) adaptive, closed-loop stimulation of STN and/or GPi.
干预措施: GPi alone (Device)
Implanted RC+S
Implanted Medtronic RC+S IPG with dual DBS electrodes in STN and GPi. DBS stimulation will be administered to: 1) STN alone, 2) GPi alone, 3) cooperative STN + GPi, and 4) adaptive, closed-loop stimulation of STN and/or GPi.
干预措施: STN + GPi (Device)
Implanted RC+S
Implanted Medtronic RC+S IPG with dual DBS electrodes in STN and GPi. DBS stimulation will be administered to: 1) STN alone, 2) GPi alone, 3) cooperative STN + GPi, and 4) adaptive, closed-loop stimulation of STN and/or GPi.
干预措施: STN alone (Device)
Implanted RC+S
Implanted Medtronic RC+S IPG with dual DBS electrodes in STN and GPi. DBS stimulation will be administered to: 1) STN alone, 2) GPi alone, 3) cooperative STN + GPi, and 4) adaptive, closed-loop stimulation of STN and/or GPi.
干预措施: Closed-loop stimulation (Device)
speech rater
blinded raters to score audio recordings of speech
结局指标
主要结局
Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 48 months after IPG implant.
时间窗: baseline and 48 months after IPG implant
Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 48 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).
Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 72 months after IPG implant.
时间窗: baseline and 72 months after IPG implant
Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 72 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).
Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 12 months after IPG implant.
时间窗: baseline and 12 months after IPG implant
Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 12 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).
Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 24 months after IPG implant.
时间窗: baseline and 24 months after IPG implant
Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 24 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).
次要结局
- Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 48 months after IPG implant.(baseline and 48 months after IPG implant)
- Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 72 months after IPG implant.(baseline and 72 months after IPG implant)
- Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 12 months after IPG implant.(baseline and 12 months after IPG implant)
- Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 24 months after IPG implant.(baseline and 24 months after IPG implant)
- Change in percentage of waking hours with good "on" time at 24 months after IPG implant.(baseline and 24 months after IPG implant)
- Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 48 months after IPG implant.(baseline and 48 months after IPG implant)
- Change in percentage of waking hours with good "on" time at 72 months after IPG implant.(baseline and 72 months after IPG implant)
- Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 12 months after IPG implant.(baseline and 12 months after IPG implant)
- Change in percentage of waking hours with good "on" time at 48 months after IPG implant.(baseline and 48 months after IPG implant)
- Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 24 months after IPG implant.(baseline and 24 months after IPG implant)
- Change in percentage of waking hours with good "on" time at 12 months after IPG implant.(baseline and 12 months after IPG implant)
- Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 72 months after IPG implant.(baseline and 72 months after IPG implant)
研究者
Dennis Turner, M.D.
Professor of Neurosurgery
Duke University