Optimizing VIM Targeting for Radiosurgery in Severe Tremor

NCT ID: NCT06698029

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-12-31

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.

Conditions

Tremor; Laser Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VIM radiosurgery with RebrAIn targeting technique

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

Group Type: EXPERIMENTAL

VIM Targeting

Intervention Type: OTHER

Targeting with the use of VIMRS-LAT-1.0

VIM radiosurgery standard targeting technique

VIM radiosurgery standard targeting technique

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

VIM Targeting

Targeting with the use of VIMRS-LAT-1.0

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Central Contacts

Jean REGIS

Role: CONTACT

jean.regis@ap-hm.fr

0491387059 ext. 33

Facility Contacts

Jean REGIS

Role: primary

jean.regis@ap-hm.fr

0491387059 ext. 33

Other Identifiers

RCAPHM23_0448

Identifier Type: -

Identifier Source: org_study_id