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NCT06698029 | NOT YET RECRUITING | Tremor

Optimizing VIM Targeting for Radiosurgery in Severe Tremor
Sponsor:

Public Assistance Hospitals of 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.

Condition or disease

Tremor

Laser Therapy

Intervention/treatment

VIM Targeting

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : SINGLE
Masking Description : the primary endpoint will be assessed at one year, in a blinded,manner
Primary Purpose : TREATMENT
Official Title : Optimization of VIM Targeting for Radiosurgery in Severe Tremor
Actual Study Start Date : 2025-01-01
Estimated Primary Completion Date : 2027-12-31
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Optimizing VIM Targeting for Radiosurgery in Severe Tremor

Location Details

NCT06698029

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France,

Public Assistance Marseille Hospitals

Marseille, France, 13354