Laser Therapy, Tremor
Conditions
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.
Interventions
OTHERVIM Targeting
Targeting with the use of VIMRS-LAT-1.0
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
the primary endpoint will be assessed at one year, in a blinded,manner
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage improvement in tremor in the treated upper limb | 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of % change in postural balance | Between inclusion and one year post-operatively (after radiosurgery) | SARA scale |
| Assessment of tolerability | At 12 months | Surgical complications: permanent or non-permanent neurological complications assessed by clinical examination |
| The percentage of improvement in quality of life | Between inclusion and one year post-operatively (after radiosurgery) | QUEST scale |
| Assess lesion location in relation to targeting | 12 months after radiosurgery | MRI |
| Medico-economic evaluation of automatic targeting compared with conventional targeting | 12 months after radiosurgery | QALY and EQ5D-5L scores |
| Assessment of cognitive performance | At one year postradiosurgery | Score of Mattis Dementia Rating Scale and the Verbal Fluency Test |
Countries
France
Contacts
Primary ContactJean REGIS
Outcome results
None listed