Optimizing VIM Targeting for Radiosurgery in Severe Tremor (OptiRS)

Optimisation du Ciblage du VIM Pour la Radiochirurgie Dans le Tremblement sévère

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Laser Therapy; Tremor
• Intervention / Treatment: Other: VIM Targeting

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean REGIS; Phone Number: 33 0491387059; Email: jean.regis@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille
    • Contact: Jean REGIS; Phone Number: 33 0491387059; Email: jean.regis@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VIM radiosurgery with RebrAIn targeting technique; VIM radiosurgery with RebrAIn targeting technique (model VIM-RS-LAT-1.0)	Other: VIM Targeting; Targeting with the use of VIMRS-LAT-1.0
No Intervention: VIM radiosurgery standard targeting technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Estimated): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Dyskinesias; Tremor
• Other Study ID Numbers: RCAPHM23_0448

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No