跳至主要内容
临床试验/NCT03600740
NCT03600740终止不适用

Advancing Pre-operative Targeting for Deep Brain Stimulation in the Globus Pallidus Internus: Functional Segmentation Based on Probabilistic Tractography

Mayo Clinic3 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年8月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
Mayo Clinic
入组人数
1
试验地点
3
主要终点
Change in Unified Parkinson's Disease Rating Scale III (UPDRS-III)

研究概览

简要总结

In the proposed pilot project, MRI data will be prospectively collected to show the feasibility of the segmentation algorithm and the potential relation to final lead positioning. Patients will be selected from those undergoing GPi DBS placement. This pilot data will serve as a basis for pursuing funding for a larger trial evaluating the prospective ability of the 3T targeting study to improve outcomes and decrease complications in GPi DBS placement. Improved outcomes and patient experience would be expected to further contribute to our facility as a center of excellence for treatment of movement disorders.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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
否

入选标准

  • •Patient with the diagnosis of Parkinson's Disease selected for placement of globus pallidus internus (GPi) deep brain stimulator (DBS)

排除标准

  • 未提供

研究组 & 干预措施

GPi DBS

Experimental

Patients selected to undergo GPi DBS placement will be eligible for enrollment in the study. In addition to standard-of-care tests, subjects will undergo an MRI consisting of the proposed novel imaging protocol prior to placement of DBS. The patient will subsequently undergo standard-of-care therapy for DBS placement. Once the stimulator has been programmed post-operatively, the stimulation parameters and corresponding clinical changes will be collected and used to model the volume of activated tissue. The patient will additionally undergo a follow-up MRI used to localize the electrode within the brain to further localize the volume of activated tissue.

干预措施: DBS Programming (Device)

结局指标

主要结局

Change in Unified Parkinson's Disease Rating Scale III (UPDRS-III)

时间窗: 3 months

Pre-operative and post-operative UPDRS-III will be assessed to measure symptom improvement and correlated with imaging data.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erik H. Middlebrooks, M.D.

Assistant Professor, Radiology and Neurosurgery

Mayo Clinic

研究点 (3)

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