Optimizing VIM Targeting for Radiosurgery in Severe Tremor

NCT06698029 | Not Yet Recruiting DMC

• 1 other identifier: RCAPHM23_0448
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The percentage of improvement in quality of life

  Between inclusion and one year post-operatively (after radiosurgery)

• Assessment of % change in postural balance

  Between inclusion and one year post-operatively (after radiosurgery)

• Assessment of tolerability

  At 12 months

• Assessment of cognitive performance

  At one year postradiosurgery

• Assess lesion location in relation to targeting

  12 months after radiosurgery

Study Arms (2)

VIM radiosurgery with RebrAIn targeting technique

EXPERIMENTAL

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

Other: VIM Targeting

VIM radiosurgery standard targeting technique

NO INTERVENTION

VIM radiosurgery standard targeting technique

Interventions

VIM Targeting OTHER

Targeting with the use of VIMRS-LAT-1.0

VIM radiosurgery with RebrAIn targeting technique

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Tremor

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jean REGIS

CONTACT

0491387059; jean.regis@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the primary endpoint will be assessed at one year, in a blinded,manner
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: November 20, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 20, 2024

Record last verified: 2024-06

Locations

FR (1)