EEG-TMS Intervening Against Postoperative Delirium
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: continuous Theta-burst stimulation, Sham.
- Кому может быть актуально
- Состояния в реестре: Postoperative Delirium. Базовые параметры: от 60 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
EEG-TMS Intervening Against Postoperative Delirium in Elderly Patients: A Randomized Clinical Trial
Обзор
Postoperative delirium is common in elderly surgical patients and is associated with complications and prolonged hospitalisation. The aim of the RECOVER study is to assess the efficacy of electroencephalo graph (EEG)-transcranial magnetic stimulation (TMS) treatment for the management of postoperative delirium.
Подробное описание
Postoperative delirium(POD), a syndrome characterized by an acute change in attention, awareness and cognition, is one of the most common postoperative complications among elderly patients. Impaired neuronal network connectivity is likely one of the several neurobiological processes that contribute to POD pathogenesis. Recently, continuous theta burst stimulation (cTBS), a pattern of TMS, was demonstrated to improve cognitive function in patients with mild cognitive impairment.Recent research suggests that cTBS has positive effect on improving the connectivity and reorganization of the brain network.This project team conducted a pilot study in the early stage and innovatively applied cTBS to treat postoperative delirium in elderly patients. The results preliminarily elucidate the safety, and feasibility of TMS in treating postoperative delirium in elderly patients.
In order to confirm the effectiveness of EEG-TMS therapy for POD and observe its impact on long-term prognosis, this project will conduct a prospective randomized controlled study to compare TMS therapy with sham stimulation therapy. The study will observe The duration of postoperative delirium during the 7-day intervention period, as well as severity of delirium, the time to successful discharge (defined as the patient surviving outside the hospital for at least 48 hours after discharge), and the 30-day and 90-day survival times, the number of patients receiving salvage drug treatment, and the number of days each patient received salvage drug treatment, the sensitivity, specificity, and predictive value of EEG. The trial will provide new ideas for the prediction and treatment of postoperative delirium in clinic.
Вмешательства
- Устройство continuous Theta-burst stimulation
Treatment parameters: each cTBS session consists of 50 Hz triplets of pulses delivered at 5 Hz for 40 s, totaling 600 pulses, and every set simulation includes 3 sessions. Electrodes are attached to designated head regions (right dorsolateral prefrontal cortex). - Устройство Sham
the treatment mode was with sham coil.
Первичные конечные точки
- Duration of postoperative delirium [Срок оценки: 7 days]
Вторичные конечные точки (5)
- Severity of delirium [Срок оценки: 7 days]
- Time to successful hospital discharge [Срок оценки: 90 days]
- Survival at 30 and 90 days [Срок оценки: 90 days]
- Number of patients receiving rescue medications [Срок оценки: 7 days]
- Total days of rescue medication use per patient [Срок оценки: 7 days]
Критерии участия
Критерии включения
- Age ≥60 years;
- Scheduled for non-cardiac surgery;
- Positive assessment for delirium via the CAM-ICU or 3D-CAM after surgery.
Критерии исключения
- Chronic use of antipsychotic medications;
- Receipt of antipsychotic drugs prior to enrollment;
- Permanently incapacitated patients (lacking decision-making capacity);
- Inability to undergo delirium assessment (e.g., due to language barriers, deafness, blindness, aphasia, or coma);
- Treatment withdrawal or brain death;
- Known pregnancy or lactation;
- Inability to obtain informed consent per national regulations;
- Patients under compulsory hospitalization (involuntary commitment) by regulatory authorities;
- Alcohol withdrawal delirium (delirium tremens);
- Contraindications to transcranial magnetic stimulation (TMS);
- Acute infectious diseases.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Renji hosipical, Shanghai Jiao Tong University School of Medicine — Шанхай
Идентификаторы
NCT: NCT07100197 · RECOVER