Optimizing VIM Targeting for Radiosurgery in Severe Tremor (OptiRS)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Not yet enrolling

Conditions: Tremor; Laser Therapy

Treatments: Other: VIM Targeting

Study type: Interventional

Funder types: Other

Identifiers

NCT06698029

RCAPHM23_0448

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

VIM radiosurgery with RebrAIn targeting technique

Experimental group

Description:

VIM radiosurgery with RebrAIn targeting technique (model VIM-RS-LAT-1.0)

Treatment:

Other: VIM Targeting

VIM radiosurgery standard targeting technique

No Intervention group

Description:

VIM radiosurgery standard targeting technique