Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06698029

Optimizing VIM Targeting for Radiosurgery in Severe Tremor

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location contact

Jean REGIS

CONTACT

[email protected]

0491387059 ext. 33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIM Targeting

Other

Targeting with the use of VIMRS-LAT-1.0

Primary outcomes

  1. Percentage improvement in tremor in the treated upper limb

    Time frame: 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 outcomes

  1. The percentage of improvement in quality of life

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

    QUEST scale

  2. Assessment of % change in postural balance

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

    SARA scale

  3. Assessment of tolerability

    Time frame: At 12 months

    Surgical complications: permanent or non-permanent neurological complications assessed by clinical examination

  4. Assessment of cognitive performance

    Time frame: At one year postradiosurgery

    Score of Mattis Dementia Rating Scale and the Verbal Fluency Test

  5. Assess lesion location in relation to targeting

    Time frame: 12 months after radiosurgery

    MRI

  6. Medico-economic evaluation of automatic targeting compared with conventional targeting

    Time frame: 12 months after radiosurgery

    QALY and EQ5D-5L scores

Study contacts

Contact information is provided by the study sponsor or research team.

Jean REGIS

CONTACT

[email protected]

0491387059 ext. 33

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: OptiRS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.