跳至主要内容
临床试验/NCT02494908
NCT02494908Unknown不适用

Can Diffusion Tensor MRI Brain Scan Demonstrate Microstructural Changes as Evidence of Neuroplasticity Following a Learning Process in Patients With Idiopathic Parkinson's Disease ?

Dr. Sharon Hassin2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
seeing evidence of microstructural brain tissue changes in Diffusion Tensor Imaging (DTI) MRI

研究概览

简要总结

As seen in previous studies Diffusion Tensor Imaging (DTI) MRI is able to detect very subtle changes in brain tissue even after a very short timescale of hours resulting from performing a cognitive task and learning, We wish to explore and compare those changes to patients with idiopathic PD (IPD) and see if there are changes in the learning process and can we detect them using widely available noninvasive techniques such as MRI.

详细描述

Aim: to utilize high sensitivity DTI MRI methodology to explore evidence for subtle microstructural brain alterations after performing a cognitive task and to compare those changes in patients with PD to healthy controls of the same age.

PD patients and controls will undergo a full cranial MRI scan for depiction of anatomy and structural abnormalities (scan duration ~40 min). Immediately afterwards the subjects will play a car race computer game (Need for Speed) for 90 minutes. Following the game, the patients will undergo an additional DTI MRI scan (~15 minutes).

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
None

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with IPD based on a clinical diagnosis of PD according to the United Kingdom Parkinson's Disease Society Brain Bank criteria (however patients with a positive family history and symmetrical onset may be included)
  • Healthy subjects should have no known neurological disease matched for age and sex with the study group

排除标准

  • History of cranial surgery, radiation therapy, tumor, stroke or significant head trauma
  • History of psychiatric disease (major depression, bipolar affective disorder, schizophrenia)
  • Patients with severe tremor or dyskinesias that may interfere with performance of the MRI scan
  • Patients with Montreal Cognitive Assessment (MoCA) score of 22 or under
  • Contraindications for MRI (metal objects: implants/shrapnel/bullet; any electrically, magnetically or mechanically activated implants: cardiac pacemakers/defibrillator, biostimulators, neurostimulators, cochlear implants, hearing aids, insulin pump; claustrophobia)
  • Subjects who are familiar and have played on multiple occasions the computer game "need for speed"

结局指标

主要结局

seeing evidence of microstructural brain tissue changes in Diffusion Tensor Imaging (DTI) MRI

时间窗: 2 hours

次要结局

未报告次要终点

研究者

发起方
Dr. Sharon Hassin
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Dr. Sharon Hassin

Dr.

Sheba Medical Center

研究点 (2)

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