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Набор по приглашению NCT07074704

tACS to Improve Negative Symptoms & Cognition in Long-term Hospitalized Schizophrenia Patients.

Без фазы С лечением Negative Symptoms in Schizophrenia Cognition Function

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: Hi-tACS, Sham Comparison.
Кому может быть актуально
Состояния в реестре: Negative Symptoms in Schizophrenia, Cognition Function. Базовые параметры: 18 лет — 65 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

Transcranial Alternating Current Stimulation (tACS) as an Augmentation Treatment for Negative Symptoms and Cognitive Deficits in Long-term Hospitalized Schizophrenia Patients

Обзор

This study aims to evaluate the efficacy of transcranial alternating current stimulation (tACS) on negative symptoms and cognitive function in long-term hospitalized patients with schizophrenia. At the same time, this study will explore the potential impact of relevant biomarkers and genetic factors on the efficacy of tACS intervention.

Подробное описание

1. Research purpose (1) This study aims to explore the synergistic therapeutic effect of tACS on negative symptoms and cognitive function in long-term hospitalized schizophrenia patients; (2) Using emotion-induced EEG activity in a virtual reality context as a biomarker, analyze its correlation with the clinical efficacy of tACS. 2. Expected results (1) It is confirmed that tACS can improve negative symptoms and cognitive function in long-term hospitalized schizophrenia patients; (2) Biomarkers can be used to predict the efficacy of tACS in improving negative symptoms and cognitive function in long-term hospitalized schizophrenia patients, and guide clinical precision application.

Вмешательства

  • Устройство Hi-tACS
    Sham tACS intervention (0 mA) Twice a day, 40 min each time, for 10 days tACS intervention (15 mA) Twice a day, 40 minutes each time, for 10 days
  • Устройство Sham Comparison
    Sham tACS intervention (0 mA) Twice a day, 40 min each time, for 10 days tACS intervention (15 mA) Twice a day, 40 minutes each time, for 10 days

Первичные конечные точки

  • Eye Tracking [Срок оценки: Day 1 before tACS intervention]
  • Eye Tracking [Срок оценки: Day 1 after tACS intervention]
  • EEG [Срок оценки: Day 1 before tACS intervention]
  • EEG [Срок оценки: Day 1 after tACS intervention]
  • Brief Negative Symptom Scale (Bnss) [Срок оценки: Day 1 before tACS intervention]
  • Brief Negative Symptom Scale (Bnss) [Срок оценки: Day 4 after tACS intervention]
  • MATRICS Consensus Cognitive Battery，MCCB [Срок оценки: Day 1 before tACS intervention]
  • MATRICS Consensus Cognitive Battery，MCCB [Срок оценки: Day 4 after tACS intervention]
  • The Clinical Assessment Interview Scale [Срок оценки: Day 1 before tACS intervention]
  • The Clinical Assessment Interview Scale [Срок оценки: Day 4 after tACS intervention]

Критерии участия

Критерии включения

  • Inclusion criteria for long-term hospitalized schizophrenia patients:
  • Diagnosed with DSM-5 schizophrenia and hospitalized for more than half a year
  • Aged between 18 and 65 years old
  • Willing to participate in the study and sign the informed consent
  • Stable condition, PANSS total score changed less than 15% at least 2 months before the study.
  • Education level above primary school
  • Normal vision or normal after correction

Inclusion criteria for normal control group:

  • No diagnosed mental illness
  • Aged between 18 and 65 years old
  • Willing to participate in the study and sign the informed consent
  • Education level above primary school
  • Normal vision or normal after correction
  • Residents living in Pudong community

Критерии исключения

Exclusion criteria for long-term hospitalization of schizophrenia patients:

  • Combined diagnosis of other mental illnesses in DSM-5
  • History of severe neurological diseases, epilepsy, craniocerebral trauma, etc.
  • Severe organic diseases of the heart, liver, kidney and other organs that are unstable
  • Infectious skin diseases
  • Use of other drugs that affect the results during the study, such as benzodiazepines, non-benzodiazepine sedatives, and psychostimulants
  • Pregnant or lactating women
  • Patients with claustrophobia
  • Patients with alcohol, drugs Abuse history
  • Patients who have received TACS treatment in the past and have no effect or intolerance

Exclusion criteria for normal control group:

  • Patients with a history of severe neurological diseases, epilepsy, craniocerebral trauma, etc.
  • Patients with severe organic diseases that cause instability of organs such as heart, liver, and kidney
  • Patients with infectious skin diseases
  • During the study, drugs that affect the results were used in combination, such as benzodiazepines, non-benzodiazepine sedatives, and psychostimulants
  • Pregnant or lactating women
  • Patients with claustrophobia
  • Patients with a history of alcohol and drug abuse -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai Pudong New Area Mental Health Center — Шанхай

Идентификаторы

NCT: NCT07074704 · PDJWWLZL

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗