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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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
Sponsor: University Hospital, Bordeaux

Current Primary Outcome:

  • LFPs records 3 month after implantation [ Time Frame: 3 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 12 month after implantation [ Time Frame: 12 month after implantation ]
    in order to characterize the features of tremor-related thalamic activity during the initiation of movement-related tremor-induced activity


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital, Bordeaux

Dates:
Date Received: June 20, 2014
Date Started: November 2014
Date Completion: December 2017
Last Updated: July 8, 2016
Last Verified: July 2016