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临床试验/NCT02346708
NCT02346708已完成不适用

Cortical Physiology as a Therapeutic Target in Parkinson's Disease Related Dementia and Cognitive Dysfunction

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
2
主要终点
Change in Magnetoencephalography (MEG) Connectivity Measures

研究概览

简要总结

This study plans to learn more about the brain function related to thinking problems in individuals with Parkinson's disease.

详细描述

Dementia is the leading cause of nursing home placement in Parkinson's disease (PD) yet little is known about the cause(s) of cognitive dysfunction in PD and there are no effective treatments. The investigators preliminary data and other published studies suggest that abnormalities in brain activity involving networks important for normal thinking and memory may contribute to cognitive dysfunction in PD and may represent a target for treatment. This proposal will identify abnormalities in cortical activity related to cognitive dysfunction in PD using magnetoencephalography and will perform a randomized control trial of bifrontal repetitive transcranial magnetic stimulation to determine the therapeutic potential of modulating this brain activity.

研究设计

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

入排标准

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

入选标准

  • Diagnosis of probable PD (using United Kingdom Brain Bank criteria)
  • Diagnosis of mild cognitive impairment
  • No unstable medical condition

排除标准

  • Features suggestive of other causes of Parkinsonism or other neurological disorders
  • Prior deep brain stimulation (DBS) or ablation surgery
  • Evidence for active depression or Hospital Anxiety and Depression Scale (HADS) score greater than or equal to 11
  • Motor symptoms expected to interfere with scanning (e.g. sever tremor)
  • Contraindications to TMS, MEG, or MRI such as pregnancy, pacemaker, unstable cardiac disease, skull lesion, claustrophobia, history of epilepsy, or on medications known to lower seizure threshold
  • Implanted electronic devices or metal

结局指标

主要结局

Change in Magnetoencephalography (MEG) Connectivity Measures

时间窗: 2 weeks

Our MEG outcome will be a change in small-worldness, global efficiency, nodal efficiency and degree distribution pre-TMS to immediately post-TMS treatment.

次要结局

  • Post-TMS Change From Baseline in Cognitive Scores(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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