Evaluating and Understanding the Effects of Deep Brain Stimulation Using Novel Electrophysiology Technique and Device in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Wireless 9-axis inertial measurement unit (IMU) with 3-axis accelerometer, gyroscope, and magnetometer will quantitatively measure the activity of neurons when high or low stimulation frequency is used.
研究概览
简要总结
The purpose of this research is to test a new recorder that can measure brain activity when stimulation is turned on during deep brain stimulation (DBS) surgery. To continue to improve DBS therapy, the investigators need to better understand the changes in the brain of people with Parkinson's disease (PD). They also need to know how this is affected by DBS. Current recorders measure activity immediately after, but not during, stimulation. Standard-of-care DBS already includes the electrical recording of brain activity during movement of arms and legs. These recordings occur during the microelectrode recording part of the surgery and are used by the medical team to determine where to place the DBS electrode.
详细描述
Deep brain stimulation (DBS) is shown to be very effective in alleviating the motor symptoms of Parkinson's disease (PD). However, its exact mechanism is not well-understood. Clinical studies have reported conflicting results regarding the effects of DBS, with some studies suggesting that it inhibits target neurons while some others suggest that it excites those neurons. One of the significant hurdles plaguing the study of DBS is the large artifacts caused by electrical stimulation. The large artifacts saturate the neural recorder and also make it take a long time to recover to its normal working conditions. Consequently, no reliable neural feedback can be recorded during the high frequency stimulation of DBS. The investigators have developed a new neural recorder that does not saturate even in the presence of large artifacts. The recorder has been validated in animal studies and recently in human experiments. The investigators propose to further develop the device to study the mechanisms of DBS: in Aim 1, they will develop an artifact-resilient neural recorder and related software suite to support intraoperative monitoring during DBS. In Aim 2, they will use the proposed device to carry out an intraoperative electrophysiological recording of the subthalamic nucleus (STN) or globus pallidus internus (GPi) in PD patients. The investigators will compare activities of the neurons when high or low stimulation frequency is used, when stimulation is delivered ipsilaterally or contralaterally, and when different temporal patterns of DBS pulses are used. Measurements of therapeutic effects in terms of tremor power will be obtained by a wireless inertial measurement unit. The investigators will correlate tremor power, neural responses, and stimulation parameters during DBS, which can provide new insights into the mechanisms of DBS. These insights can potentially lead to a better stimulation paradigm that can enhance the efficacy of DBS.
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
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has unilateral STN or GPi DBS and is approved to undergo second or contralateral side implantation;
- •Diagnosis of idiopathic PD;
- •A history of a good response to levodopa (carbidopa/levodopa) defined as at least a 30% improvement in motor unified Parkinson's disease rating scale (UPDRS) score;
- •DBS surgery at UMN is planned as part of routine clinical care.
排除标准
- •Other significant neurological disorder
- •History of dementia
- •Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
- •Pregnant women
研究组 & 干预措施
Neural recorder
干预措施: Novel neural recorder (Device)
结局指标
主要结局
Wireless 9-axis inertial measurement unit (IMU) with 3-axis accelerometer, gyroscope, and magnetometer will quantitatively measure the activity of neurons when high or low stimulation frequency is used.
时间窗: For the duration of the participant's' DBS surgery.
The investigators will compare the activity of neurons when high or low stimulation frequency is used, when stimulation is delivered ipsilaterally or contralaterally, and when different temporal patterns of DBS pulses are used within the constraints of standard clinical practice.
次要结局
未报告次要终点