Transcranial Alternating Current Stimulation on Patients with Delirium and Critical Illness (DeliTACS)
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: Transcranial alternating current stimulation (TACS), Sham TACS.
- Кому может быть актуально
- Состояния в реестре: Delirium. 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
- Финляндия
- 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
Transcranial Alternating Current Stimulation on Patients with Delirium and Critical Illness: a Randomized, Controlled, Double Blind, Proof-of-concept Pilot Study
Обзор
The goal of this clinical trial is to learn if transcranial alternating current stimulation can shorten the duration of delirium in intensive care setting. The main question it aims to answer: * Is it possible to shorten the duration of delirium with transcranial alternating current stimulation? Researchers will compare experimental treatment to sham. Participants will receive experimental or sham treatment on maximum of two days depending on their delirium status. Duration of delirium is recorded and reported as "days alive and free of delirium".
Подробное описание
Delirium is an acute-onset brain dysfunction related to extensive surgery or critical illness that leads to altered mental status and cognitive deficits. Delirium is associated with an increased length of stay in the ICU, cost of care, excessive mortality, and long-term cognitive and functional impairment. Although numerous prophylactic methods have been proposed, currently, no pharmacological or non-pharmacological methods are clinically effective. Patients with delirium have altered electroencephalography (EEG) findings among which most important are general slowing of EEG frequencies and dysconnectivity. Faster EEG frequencies, especially alpha-, beta-, and gamma-bands, are correlated with higher cognitive functions, such as memory and orientation. Transcranial alternating current stimulation (TACS) is a novel, noninvasive brain stimulation technology that cab modulate EEG frequencies by entraining of endogenous brain oscillations in response to exogenous stimuli. TACS has been shown to improve episodic memory, orientation, and cholinergic dysfunction in patients with Alzheimer's disease. TACS also increases alpha and gamma frequencies in EEG, and an increase in these frequencies is associated with the improvement of clinical symptoms. TACS has been shown to target key components of delirium pathophysiology, such as slowing of EEG frequencies and cholinergic dysfunction. Thus, we hypothesized that TACS could shorten the duration of delirium and decrease cognitive decline. We aim to test this hypothesis in a double-blind randomized trial and assess the effect of TACS on duration of delirium, EEG, biomarkers and long-term cognition.
Вмешательства
- Устройство Transcranial alternating current stimulation (TACS)
Transcranial alternating sinusoidal current at frequency of 40 Hz applied for 60 min through a pair of saline-soaked surface sponge electrodes. - Устройство Sham TACS
Sham treatment with few seconds of actual electrical current and same electrode configuration
Первичные конечные точки
- Days alive and free of delirium or coma [Срок оценки: 28 days]
Вторичные конечные точки (6)
- Biomarker profile [Срок оценки: 4 days]
- EEG changes [Срок оценки: 2 days]
- CERAD [Срок оценки: 3 and 12 months]
- TMT test A [Срок оценки: 3 and 12 months]
- TMT test B [Срок оценки: 3 and 12 months]
- Short latency inhibition [Срок оценки: 3 and 12 months]
Критерии участия
Критерии включения
- Delirium in intensive care and duration of delirium for more than 24 hours. Delirium is defined as 4 or more points on ICDSC and -1 or more points on RASS.
Критерии исключения
- Under 18 years of age, pregnancy, delirium tremens, epilepsy or history of seizures any time before first trial intervention, active psychotic disease, infection of central nervous system, acute intoxication, traumatic brain injury, stroke, intracranial bleeding and implanted electronic devices.
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
Финляндия · 1 центр
- Kuopio University Hospital — Kuopio
Идентификаторы
NCT: NCT06460363 · KUH507T056