Optimizing VIM Targeting for Radiosurgery in Severe Tremor

Not Applicable

Not yet recruiting

• Conditions: Tremor; Laser Therapy

• Registration Number: NCT06698029
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20
• Study Start: 2025-01-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage improvement in tremor in the treated upper limb	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.

Secondary Outcome Measures

Name	Time	Method
The percentage of improvement in quality of life	Between inclusion and one year post-operatively (after radiosurgery)	QUEST scale
Assessment of % change in postural balance	Between inclusion and one year post-operatively (after radiosurgery)	SARA scale
Assessment of tolerability	At 12 months	Surgical complications: permanent or non-permanent neurological complications assessed by clinical examination
Assessment of cognitive performance	At one year postradiosurgery	Score of Mattis Dementia Rating Scale and the Verbal Fluency Test
Assess lesion location in relation to targeting	12 months after radiosurgery	MRI
Medico-economic evaluation of automatic targeting compared with conventional targeting	12 months after radiosurgery	QALY and EQ5D-5L scores

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France