Набор скоро начнётся NCT06936254

One-Year Effect on Levodopa Equivalent Daily Dose of Thalamic VIM Nucleus Stimulation Compared to Subthalamic Nucleus Stimulation in Patients With Parkinson's Disease

— Наблюдательное Parkinson Disease (PD) Deep Brain Stimulation

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Parkinson Disease (PD), Deep Brain Stimulation. Базовые параметры: Без ограничений · 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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Обзор

This study compares the effects of deep brain stimulation (DBS) of the thalamic VIM nucleus versus the subthalamic nucleus (STN) on the levodopa equivalent daily dose (LEDD) in patients with Parkinson's disease. The goal is to determine whether VIM stimulation, typically used for tremor, can also reduce medication needs. It hypothesizes that STN stimulation leads to greater LEDD reduction, but VIM may offer moderate benefits in selected case

Подробное описание

Thesis Summary:

Deep brain stimulation (DBS) is a well-established therapeutic option for patients with advanced Parkinson's disease. The two most commonly targeted structures are the subthalamic nucleus (STN) and the ventral intermediate nucleus (VIM) of the thalamus. While STN stimulation is known to allow a significant reduction in the levodopa equivalent daily dose (LEDD), the effects of VIM stimulation on medication dosage remain less clear, particularly in patients selected for predominant tremor.

Objectives:

To compare the evolution of LEDD one year after DBS targeting the VIM versus the STN in patients with Parkinson's disease.

To assess whether VIM stimulation also enables a meaningful reduction in dopaminergic medication.

To contribute to refining surgical indications based on the patient's clinical profile.

Hypotheses:

STN stimulation leads to a greater reduction in LEDD compared to VIM stimulation.

VIM stimulation, though primarily used for tremor control, may result in moderate LEDD reduction in specific patient profiles.

Surgical target selection should be personalized, considering not only motor symptom control but also the impact on medication requirements.

Первичные конечные точки

Change in the levodopa equivalent daily dose (LEDD) between Parkinson's disease patients undergoing deep brain stimulation (DBS) targeting the VIM thalamic nucleus versus the STN. [Срок оценки: The primary endpoint, which is the change in levodopa equivalent daily dose (LEDD), will be measured one year post-surgery in both the VIM and STN DBS groups.]

Критерии участия

Критерии включения

Clinical diagnosis of Parkinson's disease
Underwent surgery for subthalamic nucleus (STN) or ventral intermediate nucleus (VIM) deep brain stimulation
Surgery performed at CHRU of Nancy
Surgery performed between 2014 (DxCare implementation) and 2024