此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

人类基底神经节的感觉过滤作为帕金森病的机制

2026年9月21日 更新者:J. Nicole Bentley、University of Alabama at Birmingham

The investigators are investigating the brain activity associated with sensory information in movement disorders in order to improve treatment of these symptoms beyond what is currently available.

研究概览

详细说明

The purpose of this study is to investigate the functional role of the human basal ganglia in the sensorimotor system. In particular, the investigators are interested in the possibility that the basal ganglia participate in "filtering out" sensory stimuli that are irrelevant to the current behavioral goal. Additionally, the investigators are interested in how this type of sensorimotor processing in these brain areas is related to the severity of movement disorders such as Parkinson's disease and essential tremor.

To do this, the investigators will study both healthy individuals and Parkinson's disease patients undergoing routine deep brain stimulation (DBS) surgery. During the surgery, investigators will place the DBS electrode as routinely performed and additionally place an extra, temporary "strip" electrode along the surface of the brain. Participants will then perform a short behavioral task testing sensorimotor function while investigators record the neural signals from these electrodes. The task will involve the delivery of sensory stimuli (visual, vibrotactile, electrical, and/or proprioceptive), to which the participant will be asked to perform a certain motor response. In order to fully measure the variables of interest, investigators will also attach small stickers (electrodes) to the skin of areas involved in movements for measuring muscle activity (such as the face and limbs), and may attach small, noninvasive devices around the wrist, finger, or arm (e.g., accelerometers) that measure position. The investigators may also apply EEG electrodes to the scalp to measure global brain activity or place a microphone in front of the subject to record speech.

In addition to recording this baseline brain activity, the investigators will evaluate whether deep brain stimulation and dopaminergic medication alters the recorded activity and task performance. Typical deep brain stimulation involves administering specific parameters of high-frequency electrical pulses to achieve clinical benefit. Routine operations involve testing these parameters in the OR in awake patients. For this study, investigators will administer either this high-frequency stimulation or various other patterns of stimulation (e.g., low-frequency, burst stimulation) and measure the changes in behavior and brain activity. As a method of validation, the investigators will also deliver paired pulses of stimulation that enable analysis of stimulation-evoked activity.

Finally, the investigators will correlate recorded brain activity with measures of participants' individual disease severity.

研究类型

观察性的

注册 (估计的)

30

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Alabama
      • Birmingham、Alabama、美国、35294
        • The University of Alabama at Birmingham Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 89年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with Parkinson's disease (PD) who have been approved for deep brain stimulation surgery (DBS) as part of their routine clinical care, as well as healthy controls with no known movement disorder diagnoses

描述

Inclusion criteria (PD participants):

  1. Age >18 years
  2. Clinically definite, advanced idiopathic PD based on consensus criteria.
  3. Normal, or essentially normal, preoperative brain MRI.
  4. Patient is available for follow-up visits over the length of the study
  5. Patient has elected to undergo DBS surgery as part of routine care, and subthalamic nucleus (STN) is determined as the appropriate surgical target

Inclusion criteria (control participants):

  1. Age >18 years.
  2. No diagnosis of PD, other movement disorder, or other significant neurological disease.

Exclusion criteria (PD participants):

  1. Age <18 years.
  2. Medical contraindications such as current uncontrolled hypertension, heart disease, coagulopathy, or other conditions that might increase the risk of surgery
  3. Diagnosis or suspicion of atypical Parkinsonism (PSP, MSA, CBD) or drug-induced Parkinsonism, or significant neurological disease other than PD.
  4. Diagnosis of psychogenic movement disorder based on consensus criteria
  5. Prior DBS surgery or ablation
  6. Clinical dementia and/or Dementia Rating Scale (DRS) score of <5th percentile adjusted for age and education level, based upon routine pre-op NP testing.
  7. Unable to withhold dopaminergic medications for at least 12 hours prior to scheduled visit

Exclusion criteria (control participants):

  1. Age <18 years.
  2. Previous diagnosis of PD, other movement disorder, or other significant neurological disease.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:CASE_CONTROL
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
Deep Brain Stimulation Surgery Patients

The investigators will seek to enroll people with Parkinson's disease (PD) who have been approved for deep brain stimulation surgery (DBS) as part of their routine clinical

During DBS surgery, tasks will be administered via a tablet PC or mounted monitor, and the subject may hold a response box, joystick, or dynamometer to record responses. During task periods, sensory stimuli will be delivered to the participant, who may be asked to perform a motor behavior in response. Stimuli will consist of audiovisual cues presented on a computer screen, vibration applied to specific parts of the body via a tactor, mild electrical pulses delivered through the skin of specific parts of the body via the attached EMG electrodes, and/or a movement of the arm or joint. Motor responses will consist of simple movements such as finger-tapping or hand-opening, or use of a joystick or dynamometer to move a computer cursor on the screen. Participants may be asked to respond only to a particular sensory stimulus and ignore others, in order to modulate the relevance of each stimulus to the task.

In the lab, tasks will be administered via a tablet PC or mounted monitor, and the subject may hold a response box, joystick, or dynamometer to record responses. During task periods, sensory stimuli will be delivered to the participant, who may be asked to perform a motor behavior in response. Stimuli will consist of audiovisual cues presented on a computer screen, vibration applied to specific parts of the body via a tactor, mild electrical pulses delivered through the skin of specific parts of the body via the attached EMG electrodes, and/or a movement of the arm or joint. Motor responses will consist of simple movements such as finger-tapping or hand-opening, or use of a joystick or dynamometer to move a computer cursor on the screen. Participants may be asked to respond only to a particular sensory stimulus and ignore others, in order to modulate the relevance of each stimulus to the task.

Healthy controls

The investigators will seek to enroll a cohort of age- and sex-matched healthy individuals to act as a control group. This group will NOT undergo DBS surgery

In the lab, tasks will be administered via a tablet PC or mounted monitor, and the subject may hold a response box, joystick, or dynamometer to record responses. During task periods, sensory stimuli will be delivered to the participant, who may be asked to perform a motor behavior in response. Stimuli will consist of audiovisual cues presented on a computer screen, vibration applied to specific parts of the body via a tactor, mild electrical pulses delivered through the skin of specific parts of the body via the attached EMG electrodes, and/or a movement of the arm or joint. Motor responses will consist of simple movements such as finger-tapping or hand-opening, or use of a joystick or dynamometer to move a computer cursor on the screen. Participants may be asked to respond only to a particular sensory stimulus and ignore others, in order to modulate the relevance of each stimulus to the task.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Kinematic response to stimulus (intraoperative)
大体时间:Intraoperative

Arm movements (hand position, velocity) recorded following stimulus onset, measured by joystick outputs.

Intraoperative
Kinematic response to stimulus (postoperative)
大体时间:1 month post-op

Arm movements (hand position, velocity) recorded following stimulus onset, measured by joystick outputs.

1 month post-op
Latency of response to stimulus (intraoperative)
大体时间:Intraoperative

Time from stimulus onset to start of motor response, measured by electromyography (EMG)

Intraoperative
Latency of response to stimulus (postoperative)
大体时间:1 month post-op

Time from stimulus onset to start of motor response, measured by electromyography (EMG)

1 month post-op
Neural response to stimulus
大体时间:Intraoperative

Brain activity recorded following stimulus onset, measured by local field potentials recorded from the electrocorticography (ECoG) and DBS electrodes.

Intraoperative

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Nicole Bentley, MD、The University of Alabama at Birmingham

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年6月8日

初级完成 (实际的)

2026年8月1日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2022年7月26日

首先提交符合 QC 标准的

2022年7月27日

首次发布 (实际的)

2022年8月1日

研究记录更新

最后更新发布 (实际的)

2026年9月24日

上次提交的符合 QC 标准的更新

2026年9月21日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅