Clinical trial NCT02264925: Thalamic LFPs and VIM DBS in Essential Tremor: Correlation, Evolution, and Therapeutic Perspectives
Official title: Thalamic LFPs and VIM DBS in Essential Tremor: Correlation, Evolution, and Therapeutic Perspectives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Keywords: Essential tremor
Deep brain stimulation (DBS)
Ventral intermediate Thalamus (VIM)
Local field potentials (LFPs)
Closed loop therapy
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: APTES 100 rue boileau 69006 Lyon
First posted: 2014-10-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 description: 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

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: LFPs records 3 month after implantation
timeFrame: 3 month after implantation
measure: LFPs records 12 month after implantation
timeFrame: 12 month after implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital Bordeaux, France
Study officials:
affiliation: University Hospital Bordeaux, France
name: BURBAUD Pierre, MD-PhD
role: STUDY_DIRECTOR
affiliation: IMN CNRS UMR 5293, Université Bordeaux 2 Segalen
name: Nicolas LANGBOUR, PhD
role: STUDY_CHAIR
References:
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