Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
NCT Number: NCT06698029
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.
Trial opening soon.
Get Notified18 year–85 year
All sexes
Interventional
Not applicable
Marseille, 13354, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Targeting with the use of VIMRS-LAT-1.0
Time frame: between inclusion and one year post-operatively (after radiosurgery)
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.
Time frame: Between inclusion and one year post-operatively (after radiosurgery)
QUEST scale
Time frame: Between inclusion and one year post-operatively (after radiosurgery)
SARA scale
Time frame: At 12 months
Surgical complications: permanent or non-permanent neurological complications assessed by clinical examination
Time frame: At one year postradiosurgery
Score of Mattis Dementia Rating Scale and the Verbal Fluency Test
Time frame: 12 months after radiosurgery
MRI
Time frame: 12 months after radiosurgery
QALY and EQ5D-5L scores
Contact information is provided by the study sponsor or research team.
Assistance Publique Hopitaux De Marseille
Other
Optimisation du Ciblage du VIM Pour la Radiochirurgie Dans le Tremblement sévère
Acronym: OptiRS
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