The Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Individuals With Tiletamine Use Disorder
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: Transcutaneous Auricular Vagus Nerve Stimulation, Sham Stimulation.
- Кому может быть актуально
- Состояния в реестре: Tiletamine Use Disorder, Substance Use Disorder (SUD), Drug Craving. Базовые параметры: 18 лет — 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
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Patients With Tiletamine Use Disorder: A Randomized Double-Blind Sham-Controlled Trial
Обзор
Participants diagnosed with tiletamine use disorder will be assigned to active or sham taVNS for 5 days. Clinical outcomes ( e.g., behavioral paradigms measures and clinical scales ) and physiological markers (e.g., EEG and ECG) will be evaluated at baseline, post-treatment, and 3-month follow-ups to determine therapeutic efficacy and mechanisms of action.
Подробное описание
Tiletamine use disorder has emerged as a significant public health concern characterized by persistent psychological craving and high relapse rates. This randomized, double-blind, sham-controlled clinical trial aims to evaluate whether transcutaneous auricular vagus nerve stimulation (taVNS) can reduce craving levels and improve other outcomes in individuals with tiletamine dependence. Multimodal assessments including electroencephalography (EEG), electrocardiography (ECG) , behavioral paradigms measures and clinical scales will be conducted before and after the treatment.
This study seeks to establish a non-invasive vagus nerve stimulation strategy for substance use disorders and explore the treatment mechanism.
Вмешательства
- Устройство Transcutaneous Auricular Vagus Nerve Stimulation
The stimulation duration is 40 minutes per session, administered four times daily for 5 consecutive days (20 sessions in total). - Устройство Sham Stimulation
Identical device appearance and parameters, with minimal sensory stimulation and no vagal activation. The treatment schedule is identical to that of the active group.
Первичные конечные точки
- Change of depressive symptoms [Срок оценки: Baseline, immediately after the intervention,one month after the intervention]
Вторичные конечные точки (12)
- Change of stress symptoms [Срок оценки: Baseline, immediately after the intervention, one month after the intervention,]
- Change of the sleep quality [Срок оценки: Baseline, immediately after the intervention, one month after the intervention,]
- Change of the anxiety symptoms [Срок оценки: Baseline, immediately after the intervention, one month after the intervention,]
- Change of the risky decision-making performance [Срок оценки: Baseline, immediately after the intervention]
- Changes in Negative Reinforcement Learning Behaviour [Срок оценки: Baseline, immediately after the intervention,]
- The change of alcohol craving [Срок оценки: Baseline, immediately after the intervention, one month after the intervention,]
- The change of alcohol use [Срок оценки: Baseline, immediately after the intervention, one month after the intervention,]
- The changes of Resilience [Срок оценки: Baseline, immediately after the intervention, one month after the intervention,]
- The condition of childhood experiences [Срок оценки: Baseline]
- The change of nicotine dependence [Срок оценки: Baseline, immediately after the intervention, one month after the intervention,]
- Change of the self-control ability [Срок оценки: Baseline, immediately after the intervention, one month after the intervention,]
- The changes of impulsive behavior [Срок оценки: Baseline, immediately after the intervention, one month after the intervention,]
Критерии участия
Критерии включения
- Age 18-60 years ≥6 years of education\[7.1\] DSM-5 diagnosis of substance use disorder related to tiletamine Tiletamine use ≥6 months and ≥1 time/week Ability to provide informed consent Willingness to complete follow-up assessments
Критерии исключения
- Severe cognitive impairment History of epilepsy, brain injury, neurological disease or serious psychiatric disease Use of cognition-enhancing medications within 6 months Other psychoactive substance abuse within past 5 years (except nicotine) Metal implants in the head or severe skin sensitivity
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
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Shanghai Mental Health Center — Шанхай
Идентификаторы
NCT: NCT07689981 · JDu-019