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临床试验/NCT02264925
NCT02264925已完成不适用

Thalamic LFPs and VIM DBS in Essential Tremor: Correlation, Evolution, and Therapeutic Perspectives

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
2
主要终点
LFPs records 12 month after implantation

研究概览

简要总结

The objective of this study is to characterize through spectral analysis intra-thalamic local field potentials (LFPs) recorded through implanted DBS leads during periods with and without tremor in patients suffering from severe essential tremor.

详细描述

Essential tremor (ET) is one of the most common adult movement disorders with a prevalence of 4% in the general population. Although several medications (primidone, beta-adrenergic blockers, benzodiazepines...) are commonly used, few of them are truly effective for controlling the severe forms of ET. Since 1987, an alternative has emerged with the development of high frequency deep brain stimulation (DBS) of the thalamic nucleus ventralis intermedius (VIM). This surgical technique now represents the gold standard treatment for tremor-disabled ET patients. Although VIM-DBS is clearly effective for treatment of essential tremor (ET) a partial loss of DBS effectiveness may occur over time in some patients. This loss of DBS effectiveness could be related to an adaptation of the local neuronal network to chronic stimulation (changes in synaptic plasticity). In order to avoid this problem, investigators plan to develop a intermittent mode of VIM stimulation using a new Medtronic device combining a DBS system with local field potential (LFPs) sensing capability. First, investigators propose to analyse VIM LFPs in order to define a tremor biomarker in 10 patients operated for severe ET. Thereafter, investigators will automatically detect this biomarker using a specific algorithm and use it to trigger stimulation at the onset of tremor only. Thus, this project will allow us to optimize DBS therapy in ET, by improving the longevity of implantable devices and avoiding the loss of efficacy previously reported

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suffering from severe and disabling ET with serious impact on their quality of life (QoL).
  • 18-70 years old
  • Free of evolutive and untreated psychiatric disorder
  • Tremor must be predominant in the upper limbs although it can affect the lower limbs, head and voice.
  • Affiliation to a social security system
  • Written informed consent signed by the participant and the investigator (prior to any examination required by research)

排除标准

  • Parkinsonian tremor
  • Pregnancy or lactating women
  • Severe co-morbidity (cardiac, renal or respiratory failures, evolutive cancer)
  • Impaired cognitive functions (score <130 on Mattis scale).
  • Patients with severe atrophy or lesions on MRI
  • Depression (Beck > 10)
  • Participation in another clinical research for 18 months (after surgery)

结局指标

主要结局

LFPs records 12 month after implantation

时间窗: 12 month after implantation

in order to characterize the features of tremor-related thalamic activity during the initiation of movement-related tremor-induced activity

LFPs records 3 month after implantation

时间窗: 3 month after implantation

in order to characterize the features of tremor-related thalamic activity during the initiation of movement-related tremor-induced activity

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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