跳至主要内容
临床试验/NCT06671626
NCT06671626Enrolling By Invitation不适用

Intracranial Recordings to Characterize Action Regulation Mechanisms

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2025年3月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
125
试验地点
1
主要终点
Cortical ECoG and Subcortical recordings

研究概览

简要总结

Humans can rapidly regulate actions according to evolving environmental demands, however, impairments of action regulation have been identified across a number of neurological disorders including Parkinson's Disease (PD). A key component of action regulation is action inhibition that occurs when stopping unwanted or inappropriate actions. There is mounting evidence that action inhibition also plays a critical part in selecting between competing alternative actions and switching to new actions in response to environmental changes. The investigators hypothesize that stop circuitry (involving frontal-subthalamic nucleus (STN) pathways) are involved in inhibiting unselected actions during action selection with competing alternatives (in the absence of overt stopping) and that switching motor plans also engages stopping circuitry (involving prefrontal-STN pathways) for cancelling the ongoing action, before changing to new one. The overall goal is to delineate the neural circuitry underlying a broad array of action regulation functions that involve inhibitory control, how these functions interrelate, and how they are implemented within brain networks. In this research, the investigator will take advantage of the unique opportunity provided by awake deep brain stimulation surgery to learn more about how the brain functions in a diseased state and how deep brain stimulation changes these networks to make movement more normal. The investigator will simultaneously assess cortical and subcortical electrophysiology in relation to clinical symptoms and behavioral measures and in response to deep brain stimulation in patients undergoing Deep Brain Stimulation (DBS) implantation surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Age 18 years or older.
  • Diagnosis of Parkinson's disease (rigid-akinetic subtype or tremor-dominant) based on presence of at least 2 cardinal PD features (tremor, rigidity, or bradykinesia).
  • Clinical indication and decision to proceed with subthalamic nucleus deep brain stimulation implantation.
  • L-dopa responsive with clearly defined "on" periods, with at least 30% improvement in UPDRS III scores on vs off medications (with documented ON UPDRS III scores).
  • Willingness and ability to cooperate during conscious operative procedure for up to 30 minutes.
  • Preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities.

排除标准

  • Patients with recent use (within one week) of anticoagulant or antiplatelet agent use.
  • Neurocognitive testing indicating amnestic cognitive deficits (MOCA < 24).

研究组 & 干预措施

Parkinson's disease patients

Experimental

This group consists of Parkinson's disease patients who are undergoing deep brain stimulation surgery for treatment of their movement disorder. Participants will complete behavioral assessments while receiving subcortical DBS stimulation.

干预措施: Subcortical Stimulation (Other)

结局指标

主要结局

Cortical ECoG and Subcortical recordings

时间窗: Intra-operative

Cortical ECoG and subcortical LFP recordings will occur during DBS implantation surgery during the behavioral assessments

Behavioral assessment

时间窗: Intra-operative

Each patient will complete a task that assesses action regulation through a decision making, stopping, and switching task.

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

Nader Pouratian

Professor & Chair

University of Texas Southwestern Medical Center

研究点 (1)

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