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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIM radiosurgery with RebrAIn targeting technique | Experimental | VIM radiosurgery with RebrAIn targeting technique (model VIM-RS-LAT-1.0) |
|
| VIM radiosurgery standard targeting technique | No Intervention | VIM radiosurgery standard targeting technique |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIM Targeting | Other | Targeting with the use of VIMRS-LAT-1.0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | between inclusion and one year post-operatively (after radiosurgery) |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of improvement in quality of life | QUEST scale | Between inclusion and one year post-operatively (after radiosurgery) |
| Assessment of % change in postural balance | SARA scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean REGIS | Contact | 0491387059 | 33 | jean.regis@ap-hm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille | Marseille | 13354 | France |
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| ID | Term |
|---|---|
| D014202 | Tremor |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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the primary endpoint will be assessed at one year, in a blinded,manner
| Between inclusion and one year post-operatively (after radiosurgery) |
| Assessment of tolerability | Surgical complications: permanent or non-permanent neurological complications assessed by clinical examination | At 12 months |
| Assessment of cognitive performance | Score of Mattis Dementia Rating Scale and the Verbal Fluency Test | At one year postradiosurgery |
| Assess lesion location in relation to targeting | MRI | 12 months after radiosurgery |
| Medico-economic evaluation of automatic targeting compared with conventional targeting | QALY and EQ5D-5L scores | 12 months after radiosurgery |
| D013568 |
| Pathological Conditions, Signs and Symptoms |