Идёт набор NCT06912282

Bilateral Single-Electrode VO Combined With STN-DBS for Treating Meige Syndrome

Без фазы С лечением Meige Syndrome

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: deep brain stimulation.
Кому может быть актуально: Состояния в реестре: Meige Syndrome. Базовые параметры: от 18 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: Китай
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

Evaluation of Bilateral Single-Electrode VO Combined With STN-DBS Stimulation in the Treatment of Meige Syndrome: A Prospective, Single-Center, Double-Blind, Randomized Controlled Exploratory Clinical Study

Обзор

Meige syndrome is a rare and debilitating movement disorder characterized by blepharospasm, oromandibular dystonia, and cervical muscle contractions, often refractory to pharmacological therapies. Deep brain stimulation (DBS), initially developed to treat essential tremor and Parkinson's disease, has been explored in recent years as a potential treatment for various dystonias, including Meige's syndrome. This clinical study aims to evaluate the safety and efficacy of bilateral single-electrode ventralis oralis (VO) nucleus stimulation combined with subthalamic nucleus deep brain stimulation (STN-DBS) in patients with Meige syndrome.

Подробное описание

While deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) or the globus pallidus interna (GPi) has shown moderate efficacy, incomplete symptom relief and high stimulation thresholds with associated side effects remain significant limitations. Emerging evidence suggests that dual-target neuromodulation combining STN with ventralis oralis (VO) nucleus stimulation may synergistically modulate hyperactive basal ganglia-thalamocortical circuits, potentially enhancing therapeutic outcomes.The study will involve patients diagnosed with Meige syndrome who are eligible for DBS therapy. Participants will be randomly assigned to one of two groups.The primary outcome measure is the improvement in motor symptoms, assessed using the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) before and after treatment. Secondary outcomes will include changes in quality of life, anxiety and depression scores, and any adverse effects related to the DBS procedure.The results of this study will be used to guide future clinical trials and inform the treatment options for patients with Meige syndrome.

Вмешательства

Устройство deep brain stimulation
bilateral single-electrode VO combined with STN target implantation

Первичные конечные точки

Improvement of primary symptoms [Срок оценки: 1 year after stimulation]

Вторичные конечные точки (9)

Improvement of symptoms [Срок оценки: 1 year after stimulation]
Improvement of symptoms [Срок оценки: 1 year after stimulation]
Improvement of symptoms [Срок оценки: 1 year after stimulation]
Improvement of symptoms [Срок оценки: 1 year after stimulation]
Psychological assessment [Срок оценки: 1 year after stimulation]
Psychological assessment [Срок оценки: 1 year after stimulation]
Cognitive assessment [Срок оценки: 1 year after stimulation]
Cognitive assessment [Срок оценки: 1 year after stimulation]
health-related quality of life [Срок оценки: 1 year after stimulation]

Критерии участия

Критерии включения

Must meet the clinical diagnostic criteria for Meige syndrome
Only includes patients with: Blepharospasm-type Meige syndrome and Blepharospasm with lower jaw muscle dystonia-type
All patients must have undergone at least one year of systematic and standard treatment prior to surgery