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。

Investigating the Causal Role of preSMA in Levodopa-induced Dyskinesia in Parkinson's Disease

Targeting the Pre-supplementary Motor Area With Repetitive Transcranial Magnetic Stimulation to Alleviate Levodopa-induced Dyskinesia in Parkinson´s Disease

Using a within-subject cross-over design, we will include 20 patients with Parkinson disease (PD) and peak-of-dose dyskinesia.

Patients will be studied after withdrawal from their normal dopaminergic medication.

On two separate days, each patient will receive off-line, effective (high-intensity) or ineffective (low-intensity) 1 Hz repetitive transcranial magnetic stimulation (rTMS) of the presupplementary motor area (preSMA) before functional magnetic resonance (fMRI). Immediately after the patient will perform a Go/No-Go task during fMRI in the the OFF state for 9 minutes. Then the scan is paused and the patient will receive 200 mg fast-acting oral levodopa and undergo whole-brain task-related fMRI at 3 Tesla until peak-of-dose dyskinesia will emerge.

During task-related fMRI, patients has to click on a mouse with their right hand (Right-Go), left hand (Left-Go), or no action (No-Go) in response to arbitrary visual cues.

The patients will also be tested for different aspects of impulsivity using neuropsychological questionnaires and computerized tests.

研究概览

详细说明

The most common form of levodopa-induced dyskinesias (LID) manifests when levodopa levels are highest and is referred to as peak-of-dose dyskinesia. 50% of patients experience LID after 4-6 years of treatment, reaching a frequency of 40% after 4-6 years. The main risk factors for developing LID are disease duration, levodopa dose and age-at-onset, but none of these factors alone can predict whether and when an individual patient with PD will develop LID. There is converging evidence that exogenously administered levodopa induces non-physiological release and reuptake of dopamine in the striatum. This non-physiological dopaminergic stimulation gives rise to aberrant plasticity in the striatum that causes a sensitization of the cortico-basal ganglia system to levodopa. Dyskinesia often severely affects patients' quality of life requiring advanced treatment.

Adopting a novel pharmacological fMRI (ph-fMRI) approach, our group recently identified a functional signature of LID in the human brain: To bypass any problems due to movement artefacts, fMRI was performed in the time-span between the administration of levodopa and the onset of dyskinesia. Ph-fMRI revealed that a single oral dose of levodopa caused an abnormal cortico-striatal activation and connectivity pattern in pre-SMA and putamen in LID patients relative to PD patients without LID. We predict that 1 Hz rTMS of pre-SMA will attenuate the levo-dopa-induced overactivity in the pre-SMA and putamen and normalise the pre-SMA-putamen connectivity pattern. This may possibly involve an altered interaction with the right inferior frontal gyrus (rIFG).On two separate days, each patient will receive effective (high-intensity) or ineffective (low-intensity) 1 Hz rTMS (i.e. control rTMS session) of the pre-SMA before fMRI (Off-line rTMS).

Pharmacological fMRI (ph-fMRI): Immediately after rTMS the patient will perform a Go/No-Go task during fMRI in the the OFF state for 9 minutes. Then the scan is paused and the patient will receive 200 mg fast-acting oral levodopa and undergo whole-brain task-related fMRI at 3 Tesla until peak-of-dose dyskinesia will emerge. During task-related fMRI, patients press a computer mouse with the right hand (Right-Go), left hand (Left-Go), or no action (No-Go) in response to arbitrary visual cues.

We want to include 20 patients in the final analysis of the study. In a previous comparable study we experienced a drop-out rate around a third. We therefore aim to enrol 30 patients.

研究类型

介入性

注册 (实际的)

20

阶段

  • 不适用

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

    • Capital Region
      • Hvidovre、Capital Region、丹麦、2650
        • Danish Research Centre for Magnetic Resonance

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 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Clinical diagnosis of Parkinson's Disease (Hoehn & Yahr 1-3)
  • Peak-of-dose levodopa-induced dyskinesia

Exclusion Criteria:

  • Insufficient Danish language skills
  • Neurological disease other than Parkinson's Disease
  • Major psychiatric illness
  • Sedatives or serotonergic medication in their current treatment.
  • Severe tremor
  • Montreal Cognitive Assessment score < 26

Contraindication for transcranial magnetic stimulation:

  • Epilepsy or epilepsy in 1st degree relatives
  • Contraindications for MRI-scanning:
  • Pacemaker
  • Pregnancy
  • Metallic foreign objects inside the body
  • Severe claustrophobia

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

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:REAL TMS
30 minutes of repetitive transcranial magnetic stimulation with 100% of the patients' individual resting motor threshold.

Frequency: 1 Hz., Pulse shape: biphasic, Duration: 30 minutes (1800 pulses).

Neuronavigation: MRI-guided and robot-assisted neuronavigation using Localite software and an Axilum robot.

假比较器:SHAM TMS
30 minutes of repetitive transcranial magnetic stimulation with 30% of the patients' individual resting motor threshold.

Frequency: 1 Hz., Pulse shape: biphasic, Duration: 30 minutes (1800 pulses).

Neuronavigation: MRI-guided and robot-assisted neuronavigation using Localite software and an Axilum robot.

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
Levodopa-induced change in task-related regional neural activity as indexed by the blood oxygen level dependent (BOLD) signal
大体时间:Within the first 60 minutes after levodopa intake
A single priming session of REAL rTMS over the preSMA will attenuate the abnormal pharmacodynamic BOLD response (which is an index of regional neural activity) in the cortico-basal ganglia loop after levodopa challenge compared with SHAM rTMS.
Within the first 60 minutes after levodopa intake

次要结果测量

结果测量
措施说明
大体时间
Onset of LID
大体时间:Within the first 60 minutes after levodopa intake
A single priming session of REAL rTMS over the SMA will prolong the time to onset of LID compared with SHAM.
Within the first 60 minutes after levodopa intake
Severity of LID
大体时间:Within the first 60 minutes after levodopa intake
A single priming session of REAL rTMS over the SMA will lower the the severity of LID measured on the Unified Dyskinesia Rating Scale (UDysRS) compared with SHAM.
Within the first 60 minutes after levodopa intake

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:Hartwig R Siebner, MD, DMSci、Danish Research Centre for Magnetic Resonance

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)

2017年8月1日

初级完成 (实际的)

2018年9月16日

研究完成 (实际的)

2018年9月16日

研究注册日期

首次提交

2017年6月1日

首先提交符合 QC 标准的

2017年11月24日

首次发布 (实际的)

2017年11月28日

研究记录更新

最后更新发布 (实际的)

2019年8月6日

上次提交的符合 QC 标准的更新

2019年8月3日

最后验证

2018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)?

未定

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