Clinical trial NCT06698029: Optimizing VIM Targeting for Radiosurgery in Severe Tremor
Official title: Optimisation du Ciblage du VIM Pour la Radiochirurgie Dans le Tremblement sévère
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tremor
Laser Therapy
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 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
* MATTIS ≥ 130
* Subject affiliated to or benefiting from a social security scheme
* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* Patients with a contraindication to brain MRI (pacemaker, intracerebral metal object, etc.)
* Pregnant or breast-feeding women

Primary outcomes:
measure: Percentage improvement in tremor in the treated upper limb
timeFrame: between inclusion and one year post-operatively (after radiosurgery)
Secondary outcomes:
measure: The percentage of improvement in quality of life
timeFrame: Between inclusion and one year post-operatively (after radiosurgery)
measure: Assessment of % change in postural balance
timeFrame: Between inclusion and one year post-operatively (after radiosurgery)
measure: Assessment of tolerability
timeFrame: At 12 months
measure: Assessment of cognitive performance
timeFrame: At one year postradiosurgery
measure: Assess lesion location in relation to targeting
timeFrame: 12 months after radiosurgery
measure: Medico-economic evaluation of automatic targeting compared with conventional targeting
timeFrame: 12 months after radiosurgery
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
References: