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临床试验/NCT04581941
NCT04581941已完成不适用

Deep Brain Stimulation Effects in Essential Tremor: Time Course of Electrophysiological Changes in Treatment

University of Florida1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2020年12月5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
4
试验地点
1
主要终点
Fahn- Tolosa- Marin Tremor Rating Scale

研究概览

简要总结

Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory essential tremor. However, DBS programming is not standardized and multiple clinic visits are frequently required to adequately control symptoms. The investigators aim to longitudinally record brain signals from patients using a novel neurostimulator that can record brain signals. The investigators will correlate brain signals to clinical severity scores to identify pathological rhythms in the absence of DBS, and we will study the effects of DBS on these signals in order to guide clinical programming.

详细描述

The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. The is now the ability to stream brain signals from a newly FDA approved device, the Medtronic Percept. The investigators will study the longitudinal effects of DBS on the brain signals that are found to correlate with tremor severity as measured with wireless wearable sensors.

研究设计

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

入排标准

年龄范围
21 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

Fahn- Tolosa- Marin Tremor Rating Scale

时间窗: 6 months

A clinical scale of tremor severity (0-4, 0:no symptoms, 4:extreme)

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 (1)

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