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临床试验/NCT03753945
NCT03753945已完成不适用

Spine MRI in Patients With Deep Brain Stimulation (DBS)

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2019年3月1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
17
试验地点
1
主要终点
Incidence of MRI-related Adverse Events [Safety]

研究概览

简要总结

Magnetic resonance imaging (MRI) of patients implanted with deep brain stimulation (DBS) is under strict safety guidelines. Depending on the body part being imaged, the safety may vary.

Many DBS patients will need a spine MRI based on their clinical symptoms. However, the vendor safety guidelines are limiting in terms of possible MR pulse sequences. Based on phantom safety data, we designed a set of MR pulse sequences deemed as safe as possible and the protocol allows acquisition of diagnostic quality MRI images.

详细描述

The patients who clinically require a spine MRI will undergo a spine MRI with our designed protocols to obtain diagnostic quality images. Furthermore, a limited brain MRI will be done before and after to ensure no peri-electrode tissue changes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incidence of MRI-related Adverse Events [Safety]

时间窗: Immediately after the MRI

Assess for adverse events as seen on clinical examination

次要结局

  • Assessment of Peri-electrode Tissue Changes (MRI)(Immediately after the MRI)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andres M. Lozano

Neurosurgeon

University Health Network, Toronto

研究点 (1)

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