Optimizing VIM Targeting for Radiosurgery in Severe Tremor

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with a contraindication to brain MRI (pacemaker, intracerebral metal object, etc.)

Pregnant or breast-feeding women

Trial design

Design model

Parallel

Treatments tested in this trial

  • VIM Targeting

    Other intervention

    Targeting with the use of VIMRS-LAT-1.0

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: VIM radiosurgery with RebrAIn targeting techniqueExperimental treatment 1 intervention
Group B: VIM radiosurgery standard targeting techniqueNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

The percentage of improvement in quality of life

QUEST scale

Time frame
Between inclusion and one year post-operatively (after radiosurgery)
2

Assessment of % change in postural balance

SARA scale

Time frame
Between inclusion and one year post-operatively (after radiosurgery)
3

Assessment of tolerability

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

Time frame
At 12 months
4

Assessment of cognitive performance

Score of Mattis Dementia Rating Scale and the Verbal Fluency Test

Time frame
At one year postradiosurgery

Other outcomes

Sponsors and contacts

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