Набор скоро начнётся NCT06698029

Optimizing VIM Targeting for Radiosurgery in Severe Tremor

Без фазы С лечением Tremor Laser Therapy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: VIM Targeting.
Кому может быть актуально: Состояния в реестре: Tremor, Laser Therapy. Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Другое VIM Targeting
Targeting with the use of VIMRS-LAT-1.0

Первичные конечные точки

Percentage improvement in tremor in the treated upper limb [Срок оценки: between inclusion and one year post-operatively (after radiosurgery)]

Вторичные конечные точки (6)

The percentage of improvement in quality of life [Срок оценки: Between inclusion and one year post-operatively (after radiosurgery)]
Assessment of % change in postural balance [Срок оценки: Between inclusion and one year post-operatively (after radiosurgery)]
Assessment of tolerability [Срок оценки: At 12 months]
Assessment of cognitive performance [Срок оценки: At one year postradiosurgery]
Assess lesion location in relation to targeting [Срок оценки: 12 months after radiosurgery]
Medico-economic evaluation of automatic targeting compared with conventional targeting [Срок оценки: 12 months after radiosurgery]

Критерии участия

Критерии включения

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).