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临床试验/NCT06485986
NCT06485986招募中不适用

Frontosubthalamic Network Dynamics and Their Modulation During Impulse Control and Decision Making in Parkinson's Disease

University of Oxford2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Identify effect of therapeutic STN-DBS on frontosubthalamic networks in PD related ICDs during decision making and impulse control

研究概览

简要总结

The goal of this experimental study with is to understand the underlying mechanisms behind the increase in impulsivity seen in some patients that undergo deep brain stimulation of the subthalamic nucleus for Parkinson's Disease. The main questions it aims to answer are:

What are the distributed network effects of deep brain stimulation to the subthalamic nucleus? How does this correlate with increased impulsivity? Can alternative stimulation settings be used to minimize these?

Participants will complete decision-making tasks whilst their deep brain stimulation devices are turned on and off with simultaneous magnetoencephalography recordings (a type of non-invasive brain scan that measures brain activity in real-time)

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Diagnosed with Parkinson's disease who have required implanted STN electrodes for DBS in addition to their dopamine replacement therapy.
  • Diagnosed with or without (control group) impulse control disorders since the diagnosis of Parkinson's Disease.
  • Participant willing and able to sit in the MEG scanner and follow instructions.
  • Participant willing and able to delay their morning dose of dopamine replacement therapy for up to four hours (180 minutes experimental time + journey time).

排除标准

  • Patients with extreme language barrier that cannot understand the purpose or instructions of the study despite the use of an interpreter.
  • Other implanted medical devices that may cause artefacts during MEG recordings.
  • Participants with a history of co-morbid neurological disorders.
  • Participant enrolled onto another clinical trial related to a neurological disorder (including Parkinson's disease) that may interfere with the results of this study.
  • Participants who are unable to sit still in a MEG scanner for the duration of this experiment e.g. patients with chronic pain or osteoarthritis. This will be assessed with their primary clinician

结局指标

主要结局

Identify effect of therapeutic STN-DBS on frontosubthalamic networks in PD related ICDs during decision making and impulse control

时间窗: 12 months

Correlation between response time and accuracy with electrophysiological signatures of neural activity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Frontosubthalamic Networks in Parkinson's Disease. | 临床试验