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临床试验/NCT03819738
NCT03819738招募中不适用

Functional Magnetic Resonance Imaging in Deep Brain Stimulation

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年3月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Determine the functional networks that are involved in DBS

研究概览

简要总结

With fMRI, we want to understand the mechanisms of brain neuromodulation in (dys)functional brain circuits, to obtain knowledge on involved brain networks in DBS.

详细描述

Deep brain stimulation represents a neurosurgical treatment option for specific refractory neurological and psychiatric disorders. In these patients a specific brain target is stimulated through an electrode with the use of an implantable pulse generator (IPG). In a functional MRI (fMRI) experiment, the investigators intend to perform imaging during stimulation ON and compare brain activations with the stimulation OFF condition. In this way, they aim to elucidate the involved brain network in deep brain stimulation. Since the connectivity of deep brain structures is complex, different activation patterns are expected in-between subjects and conditions. If specific activation patterns during the stimulation ON condition can be related to treatment response, this is of important clinical value. These findings can lead to an optimization of the deep brain target or even to different useful targets for brain stimulation.

研究设计

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

入排标准

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

入选标准

  • Deep brain stimulation system implanted

排除标准

  • Children and pregnant women will be excluded. Failure to follow to protocol is also an exclusion criterion.

结局指标

主要结局

Determine the functional networks that are involved in DBS

时间窗: 5 years

To determine differences in activations of functional networks between ON and OFF DBS in an fMRI experiment,

To link the involved network to outcome in DBS therapy

时间窗: 5 years

To link specific activation patterns during ON-OFF with a clinical value

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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