跳至主要内容
临床试验/NCT05482126
NCT05482126招募中不适用

Sensory Filtering in the Human Basal Ganglia as a Mechanism of Parkinson's Disease

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年6月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Latency of response to stimulus (intraoperative)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (PD participants):
  • Age >18 years
  • Clinically definite, advanced idiopathic PD based on consensus criteria.
  • Normal, or essentially normal, preoperative brain MRI.
  • Patient is available for follow-up visits over the length of the study
  • 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):
  • Age >18 years.
  • No diagnosis of PD, other movement disorder, or other significant neurological disease.

排除标准

  • (PD participants):
  • Age <18 years.
  • Medical contraindications such as current uncontrolled hypertension, heart disease, coagulopathy, or other conditions that might increase the risk of surgery
  • Diagnosis or suspicion of atypical Parkinsonism (PSP, MSA, CBD) or drug-induced Parkinsonism, or significant neurological disease other than PD.
  • Diagnosis of psychogenic movement disorder based on consensus criteria
  • Prior DBS surgery or ablation
  • 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.
  • Unable to withhold dopaminergic medications for at least 12 hours prior to scheduled visit
  • Exclusion criteria (control participants):
  • Age <18 years.
  • Previous diagnosis of PD, other movement disorder, or other significant neurological disease.

研究组 & 干预措施

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

干预措施: Intraoperative Behavioral Testing (Diagnostic Test)

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

干预措施: Behavioral Testing (Diagnostic Test)

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

干预措施: Behavioral Testing (Diagnostic Test)

结局指标

主要结局

Latency of response to stimulus (intraoperative)

时间窗: Intraoperative

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

Latency of response to stimulus (postoperative)

时间窗: 1 month post-op

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

Neural response to stimulus

时间窗: Intraoperative

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

Kinematic response to stimulus (intraoperative)

时间窗: Intraoperative

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

Kinematic response to stimulus (postoperative)

时间窗: 1 month post-op

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zachary Irwin

Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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