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Not yet recruiting NCT06698029

Optimizing VIM Targeting for Radiosurgery in Severe Tremor

No phase Interventional Tremor Laser Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VIM Targeting.
Who it may be relevant to
Registry conditions: Tremor, Laser Therapy. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other VIM Targeting
    Targeting with the use of VIMRS-LAT-1.0

Primary outcome measures

  • Percentage improvement in tremor in the treated upper limb [Time frame: between inclusion and one year post-operatively (after radiosurgery)]
Secondary outcome measures (6)
  • The percentage of improvement in quality of life [Time frame: Between inclusion and one year post-operatively (after radiosurgery)]
  • Assessment of % change in postural balance [Time frame: Between inclusion and one year post-operatively (after radiosurgery)]
  • Assessment of tolerability [Time frame: At 12 months]
  • Assessment of cognitive performance [Time frame: At one year postradiosurgery]
  • Assess lesion location in relation to targeting [Time frame: 12 months after radiosurgery]
  • Medico-economic evaluation of automatic targeting compared with conventional targeting [Time frame: 12 months after radiosurgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Assistance Publique Hopitaux de Marseille — Marseille

Identifiers

NCT: NCT06698029 · RCAPHM23_0448

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗