跳至主要内容
临床试验/NCT07231302
NCT07231302已完成不适用

Determination of Stereotactic Landmarks Based on Computer-generated Images and Electrophysiological Recording Patterns for Electrode Implantation for Stimulation of the Dentate Nucleus and Its Fiber Projections Aiming the Treatment of Movement Disorders, Like Secondary Dystonia, Ataxia, Tremor (Essential and Symptomatic)

Kleber Paiva Duarte0 个研究点目标入组 20 人开始时间: 2016年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
主要终点
DSB in the dentate nucleus

研究概览

简要总结

Electrical stimulation (DBS) through electrodes implanted in the dentate nucleus of the cerebellum for the treatment of tremor intractable with medication, dystonia due to cerebrovascular disease (stroke), sequelae of traumatic brain injury, and ataxia (a disease that causes incoordination of movements). Use of advanced magnetic resonance imaging techniques and recording of nerve cell activity in this nucleus

详细描述

To establish anatomical and functional criteria, based on stereotactic imaging and electrophysiological recordings, that enable the precise implantation of electrodes in the DN and its efferent projections for the treatment of movement disorders. This study aims to describe a surgical technique for the implantation of deep brain electrodes targeting the stimulation (DBS) of the dentate nucleus (DN) and its efferent projections, supported by the magnetic resonance imaging (MRI), the diffusion tensor imaging (DTI), reformatted in the stereotomographic images and related to stereotactic landmarks and checked with semimicro deep brain recording.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Retrospective

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

  • Age 18 or older
  • Clinical diagnosis of cerebellar syndrome resulting from stroke and spinocerebellar degeneration, intractable tremor, primary or secondary dystonia, refractory to drug and physiotherapy treatment;
  • Signed the term of free and informed consent

排除标准

  • Age under 18 years;
  • Presence of severe anatomical deformities in the cerebellum and/or brainstem;

结局指标

主要结局

DSB in the dentate nucleus

时间窗: From enrollment to the end of treatment at 16 weeks

All stereotactic image calculations the definitive location of the implants in relation to the targets proposed in the ND, were reanalyzed in a digital environment that included co-registration of the preoperative MRI, DTI, and stereotomograph

次要结局

未报告次要终点

研究者

发起方
Kleber Paiva Duarte
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kleber Paiva Duarte

assistant professor

University of Sao Paulo

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