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临床试验/NCT02585154
NCT02585154已完成不适用

Studying Movement Control in Parkinson's Disease Using Closed Loop Deep Brain Stimulation

University of Oxford4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
4
主要终点
Ability to suppress inappropriate movements as measured by motor tasks (accuracy measured in %)

研究概览

简要总结

Parkinson's disease is a common, disabling, progressive condition characterised by severe problems with movement for which medical treatment in the longer term can be unsatisfactory. Deep brain stimulation is a treatment, which directly stimulates the nerve cells affected inside the brain to help overcome the difficulties with movement. Classically, deep brain stimulation stimulates in a manner that is constant and independent of a patients underlying condition as reflected in their brainwave activity. Recent research has suggested that adjusting deep brain stimulation in real time using analyses of brain signals recorded from deep brain stimulation electrodes (termed closed loop deep brain stimulation) nay be better than classical deep brain stimulation in alleviating difficulties with movement. However, it remains unclear whether closed-loop deep brain stimulation also leads to fewer unwanted side effects on movement control. In order to answer this question, the investigators will analyze deep brain stimulation activity and activity recorded from the surface of the head in Parkinson's disease patients undergoing deep brain stimulation surgery. During the recordings patients will perform different movement tasks. Deep brain stimulation has been found to reduce patients' ability to suppress inappropriate movements in certain tasks and performance in these tasks will be the core point of interest. The recordings will be conducted three times: During closed loop deep brain stimulation, classical deep brain stimulation and while the stimulator is turned off. This will allow the investigators to assess putative differences in the effect of closed loop and classical deep brain stimulation with regards to wanted and unwanted effects on movement control and to elucidate their correlates in the brain.

详细描述

Study Summary Patients will undergo standard 2 part deep brain stimulation implantation (electrode implantation day 1, battery and stimulator implantation approximately day 7, home approximately day 10). The experiments will be performed whilst the patients are inpatients between the two operations and will therefore not require any extra visits or delay in starting therapeutic deep brain stimulation. This paradigm is the standard method for conducting local field potential research in human and represents the paradigm by which the vast majority of previous research in this area has been conducted. Patients will be tested either at Oxford University Hospitals National Health Service Trust or University College London National Health Service Trust.

At least 24h after electrode implantation (first of the two surgeries) patients will be approached about the study and left with the patient information sheet for 24 hours, before further discussion, and, if appropriate consent.

Thereafter, the following procedures will be undertaken:

  1. The subjects will participate in a short assessment testing their cognitive function and fill out questionnaires regarding handedness and impulsiveness traits . Furthermore, they will be introduced to the three motor tasks, which they will perform during the definitive test. Together, these assessments will take approximately one hour.

Prior to the next steps, which will be conducted on the same day or 1-3 days later(depending on the preferences of the participant), participants will be requested to withhold their usual medication overnight so that they are assessed off medication on the morning of the tests. 2. Deep brain stimulation will be evaluated in order to find the best stimulation parameters ( the settings, which yield the best clinical benefit) for each individual patient. This will take approximately 1 hour and is part of the standard clinical procedure. 3. Recordings will be made from the deep brain stimulation electrodes and electrodes placed on the surface of the head in order to assess activity and communication within the brain. During the recordings participants will perform three motor tasks using their hands. In the first two tasks they have to decide whether to press a button on a computer mouse or refrain from a response depending on the nature of some small dots moving in different directions on a computer screen. This will allow assessing patients' ability to perform and inhibit movements. In the third task they are asked to press a button depending on the direction of an arrow presented in the middle of the screen, while ignoring arrows around this central cue. This additional task will allow assessing patients' ability to control conflicting response tendencies. The recordings will be conducted three times: During closed loop deep brain stimulation, open loop deep brain stimulation and while the stimulator is turned off. The order of these sessions will be randomized and counter-balanced across participants. The experimental recordings will take approximately 2 hours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Blinded video assessment

入排标准

年龄范围
18 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Study participants will be Parkinson's disease patients undergoing deep brain stimulation of the subthalamic nucleus (STN).
  • Whether or not a patient is selected for deep brain stimulation surgery is determined by the patient's clinical team purely on independent clinical grounds.
  • Only those patients who have been accepted for deep brain stimulation treatment by their clinical neurologist and functional neurosurgeon will be introduced to the project and have their details passed on to the research team for further information and formal consenting.
  • Able to give informed consent.

排除标准

  • Lack of capacity to consent (judged by the clinician taking consent as not having sufficient mental capacity to understand the study and its requirements). This is including anyone who, in the opinion of the clinician taking consent, is unlikely to retain sufficient mental capacity for the duration of their involvement in the study.
  • Cognitive impairment/lack of capacity to perform experimental task.

结局指标

主要结局

Ability to suppress inappropriate movements as measured by motor tasks (accuracy measured in %)

时间窗: Outcome will be assessed on day of experimental sessions (interventions), i.e. the time frame corresponds to the study duration.

Ability to suppress inappropriate movements as measured by motor tasks (response time measured in s)

时间窗: Outcome will be assessed on day of experimental sessions (interventions), i.e. the time frame corresponds to the study duration.

次要结局

  • Local field potential spectra during open-loop deep brain stimulation, closed-loop deep brain stimulation and no deep brain stimulation(Outcome will be assessed on day of experimental sessions (interventions), i.e. the time frame corresponds to the study duration.)
  • Connectivity between neural regions during open-loop deep brain stimulation, closed-loop deep brain stimulation and no deep brain stimulation(Outcome will be assessed on day of experimental sessions (interventions), i.e. the time frame corresponds to the study duration.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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