About this trial
Essential tremor is a common neurological disease, the most severe form of which combines postural and intention tremor, with significant physical, psychological and social repercussions. It is in these most severe forms that surgical lesioning of the ventro-intermediate nucleus of the thalamus (VIM) has been proposed. The VIM and its region of interest are almost impossible to identify directly on imaging (especially MRI), as it is part of the thalamus, which has the same intensity. To identify it, teams use average coordinates from stereotactic atlases (imprecise due to the high inter-individual variability of brain anatomy) or retrospective series of implanted patients. The hypothesis of the present trial is that the VIM-RS-LAT-1.0 algorithm developed by RebrAIn for radiosurgery will enable targeting that is at least as effective as conventional targeting. This is a single-center, controlled study, the primary endpoint of which will be assessed at one year, in a blinded, phase 3, comparative, non-inferiority, randomized study in two parallel groups of patients with severe tremor undergoing radiosurgery. In the control group, VIM will be targeted conventionally, and in the experimental group, VIM will be targeted by the RebrAIn algorithm (VIM-RS-LAT-1.0 model) of radiosurgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Advanced, disabling, drug-resistant essential tremor
Patient selected as part of the multidisciplinary concertation meeting on abnormal movements
Patient aged 18 to 85
Brain MRI showing no anatomical abnormality contraindicating radiosurgical procedure
Disqualifiers
Patients with a contraindication to brain MRI (pacemaker, intracerebral metal object, etc.)
Pregnant or breast-feeding women
Trial design
Parallel
Treatments tested in this trial
VIM Targeting
Other interventionTargeting with the use of VIMRS-LAT-1.0
Treatment groups
Trial outcomes
Primary outcomes
Percentage improvement in tremor in the treated upper limb
Assessed on a composite tremor assessment criterion that strictly replicates the endpoint of the prospective study. The percentage will be considered as a continuous variable, between 0 and 100%, and will be assessed blindly by a single practitioner.
Secondary outcomes
The percentage of improvement in quality of life
QUEST scale
Assessment of % change in postural balance
SARA scale
Assessment of tolerability
Surgical complications: permanent or non-permanent neurological complications assessed by clinical examination
Assessment of cognitive performance
Score of Mattis Dementia Rating Scale and the Verbal Fluency Test
Sponsors and contacts
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