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临床试验/NCT02443181
NCT02443181已完成不适用

The Application of DBS Technologies for Demand-driven Management of Essential Tremor

University of Washington1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
1
主要终点
Number of participants with adverse events

研究概览

简要总结

This study evaluates the effectiveness of tremor control using various strategies for implementing demand-driven thalamic deep brain stimulation (DBS) for essential tremor. Therapeutic stimulation at the Vim nucleus of the thalamus will be initiated and modulated using signals derived from external sensors (e.g. EMG, accelerometer) and cortical or thalamic electrodes.

详细描述

Essential tremor is effectively treated with deep brain stimulation of the ventralis intermedius nucleus of the thalamus, presumably because high-frequency stimulation disrupts aberrant cerebellar-thalamic input. For the most part, patients with essential tremor have a kinetic tremor that is present or worsened with movement. However, DBS therapy is currently continuous, and thus, stimulation occurs when the patient will not benefit symptomatically from treatment. This exposes the patient to unnecessary stimulation, which can lead to unnecessary usage of battery, unnecessary exposure to stimulation side-effects, and can possibly contribute to tolerance to DBS therapy.

One possible solution is selective stimulation when movement is required. This study will determine signals predictive of motor activity using external sensors such as EMG, and cortical biomarkers of real and imaginary movement that are well-characterized.

The primary aim is to demonstrate successful initiation and modulation of DBS therapy using the Activa PC+S system and implanted cortical or thalamic electrodes. Putative improvements in battery usage related to stimulation on-time and definition of coupling signals between thalamus and cortex that characterize tremor state are secondary outcomes.

研究设计

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

入排标准

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

入选标准

  • •Appropriate candidates for DBS with essential tremor

排除标准

  • •Not meeting inclusion criteria based on tremor amplitude, neuropsychological testing, etc.
  • •Prior trauma to the brain on side of putative implantation of stimulator

研究组 & 干预措施

Activa PC+S

Experimental

Patients will be implanted with standard DBS electrodes for treatment of essential tremor, at the Vim nucleus of the thalamus, and an additional subdural electrode array overlying hand motor cortex.. The patient will receive standard of care programming for thalamic stimulation for essential tremor. During research study visits, implementation and evaluation of closed-loop DBS using the PC+S system will be performed.

干预措施: Activa PC+S (Device)

结局指标

主要结局

Number of participants with adverse events

时间窗: 18 months

Adverse events will be tracked using CTCAE terminology.

次要结局

  • Battery usage using demand-driven strategies for tremor control(18 months)

研究者

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

Andrew Ko

Assistant Professor, Department of Neurological Surgery

University of Washington

研究点 (1)

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