Directional PSA Versus STN DBS for TD-PD
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: directional Deep brain stimulation.
- Кому может быть актуально
- Состояния в реестре: Parkinsons Disease (PD). Базовые параметры: 18 лет — 80 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
Directional Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Tremor-dominant Parkinson's Disease: a Prospective, Randomized, Double-blinded, Cross-over Trial
Обзор
The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) using directional lead for the treatment of tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.
Подробное описание
This single-center trial utilizes directional deep brain stimulation (DBS) current-steering technology to compare the clinical efficacy and tolerability of the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of tremor-dominant Parkinson's disease (TD-PD) within the same subject. The study is optimized into a two-phase framework to maximize patient safety and protocol compliance:
Phase 1: Two-month post-implantation, acute mapping is conducted to define the therapeutic window for PSA and STN configurations in a blinded randomized order. If a configuration induces immediate, unmanageable adverse events before reaching efficacy, it is classified as "intolerant" and excluded from that participant's subsequent chronic phase.
Phase 2 (Chronic Crossover): Participants with tolerated configurations are entered into a chronic randomized phase with a blinded sequence of 2-month PSA or STN chronic stimulation. Following the core two-arm crossover, all eligible patients transition into an open-label, exploratory sequential add-on phase of 2-month with combined PSA+STN stimulation to evaluate potential synergistic benefits.
All participants will then be followed-up up to 12 months after surgery.
Вмешательства
- Устройство directional Deep brain stimulation
active directional DBS with optimal stimulating parameters
Первичные конечные точки
- Change from Baseline in Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III tremor subscore Between PSA and STN Stimulation in the chronic randomized phase [Срок оценки: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)]
Вторичные конечные точки (6)
- Change from Baseline in Fahn-Tolosa-Marin Clinical Rating Scale Between PSA and STN Stimulation in the chronic randomized phase [Срок оценки: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)]
- Change from Baseline in Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III total score Between PSA and STN Stimulation in the chronic randomized phase [Срок оценки: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)]
- Change from Baseline in Berg Balance Scale score Between PSA and STN Stimulation in the chronic randomized phase [Срок оценки: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)]
- Change from Baseline in 39-item Parkinsons disease questionnaire Between PSA and STN Stimulation in the chronic randomized phase [Срок оценки: Baseline (pre-operation) and the end of each 2-month stimulation period (Month 4 and Month 6)]
- Proportion of Participants with Acute Phase Intolerance to Single-Target Stimulation [Срок оценки: Up to 2 months after sugery]
- Adverse events [Срок оценки: Up to 12 months after surgery]
Критерии участия
Критерии включения
- diagnosis of idiopathic Parkinson's disease
- tremor-dominant subtype in the off-medication condition
- modified Hoehn-Yahr scale of 2 to 4 in the off-medication condition
- receiving regular anti-parkinsonian drugs for more than 6 weeks
- good compliance and written informed consent provided
Критерии исключения
- Atypical parkinsonism
- History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery
- Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
- Presence of anatomical abnormalities in the target region
- Clinically significant medical history that would increase pre-/post-operative complications
- Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Шанхай
Идентификаторы
NCT: NCT07700862 · dPSA-STNforTD-PD