An interventional study of VIM Targeting in Tremor and Laser Therapy, sponsored by Assistance Publique Hopitaux De Marseille. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Treatment
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.
158 studies on the registry are indexed under Tremor; 44 are open to participants now.
This study's planned enrollment of 40 is above the median of 33 across 109 interventional studies indexed under Tremor.
Browse Tremor studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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Contraindication
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VIM radiosurgery with RebrAIn targeting technique (model VIM-RS-LAT-1.0)
Other: VIM Targeting
VIM radiosurgery standard targeting technique
Targeting with the use of VIMRS-LAT-1.0
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)
The percentage of improvement in quality of life
QUEST scale
Time frame: Between inclusion and one year post-operatively (after radiosurgery)
Assessment of % change in postural balance
SARA scale
Time frame: Between inclusion and one year post-operatively (after radiosurgery)
Assessment of tolerability
Surgical complications: permanent or non-permanent neurological complications assessed by clinical examination
Time frame: At 12 months
Assessment of cognitive performance
Score of Mattis Dementia Rating Scale and the Verbal Fluency Test
Time frame: At one year postradiosurgery
Assess lesion location in relation to targeting
MRI
Time frame: 12 months after radiosurgery
Medico-economic evaluation of automatic targeting compared with conventional targeting
QALY and EQ5D-5L scores
Time frame: 12 months after radiosurgery
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Dec 2027, 35 months later.
Of 36 non-industry interventional studies with no phase under Tremor, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 68. This study's planned 35 months is close to that.
Counting every sponsor, half of 40 studies reached it within 28 months; a quarter within 10 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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