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Идёт набор NCT06470516

The Hi-tACS on Cognitive Function in Patients With Schizophrenia

Без фазы С лечением Schizophrenia

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: high-frequency transcranial alternating current stimulation, sham high-frequency transcranial alternating current stimulation.
Кому может быть актуально
Состояния в реестре: Schizophrenia. 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Impact of High-frequency Transcranial Alternating Current Stimulation (Hi-tACS) on Cognitive Function in Patients With Schizophrenia

Обзор

This study is a double-blind, randomized, controlled intervention study aimed at exploring whether high-frequency transcranial alternating current stimulation (Hi-tACS) can improve cognitive impairment in patients with schizophrenia.

Подробное описание

Schizophrenia is a chronic, severe mental disorder characterized by a high suicide rate and significant disability. Cognitive impairment is one of the core symptoms of schizophrenia, with approximately 98% of patients experiencing a decline in cognitive function compared to pre-illness levels. Research has found that individuals with schizophrenia show significant impairments in seven domains, including reaction time, attention, working memory, verbal learning and memory, visual learning and memory, logical reasoning, and social cognition.

Pharmacological treatment remains the primary approach for managing schizophrenia. However, cognitive impairment in individuals with schizophrenia often does not respond well to medication. Additionally, electroconvulsive therapy (ECT) may have potential cognitive side effects. Transcranial alternating current stimulation (tACS), a form of noninvasive brain stimulation, has been found in several studies to improve cognition. However, its effectiveness is not yet clear.

Conventional tACS utilizes weak currents below 4mA, which can only directly stimulate certain cortical areas and indirectly stimulate deep brain structures. Moreover, the targeting of specific brain regions can be complex, and users may experience a sensation of heat on the skin where the electrodes come into contact.High-frequency transcranial alternating current stimulation (Hi-tACS) employs electrical currents greater than 10mA, typically ranging from 10-15mA. Unlike conventional tACS, Hi-tACS can apply stimulation to the entire brain, potentially enhancing its therapeutic effects. Moreover, Hi-tACS does not require precise targeting and is generally well-tolerated without any discomfort during the stimulation. It is considered a promising and potentially safe treatment modality for cognitive impairment in schizophrenia.

Вмешательства

  • Устройство high-frequency transcranial alternating current stimulation
    The experimental group received real stimulation of high-frequency transcranial alternating current stimulation (Hi-tACS).The treatment duration is 30 days, with two sessions per day, each lasting 40 minutes.The experimental group received Hi-tACS with parameters set at 77.5Hz and 15mA.
  • Устройство sham high-frequency transcranial alternating current stimulation
    The the control group received sham stimulation of high-frequency transcranial alternating current stimulation (Hi-tACS).The treatment duration is 30 days, with two sessions per day, each lasting 40 minutes.The experimental group received Hi-tACS with parameters set at 0mA

Первичные конечные точки

  • scores of Repeatable Battery for the Assessment of Neuropsychological Status [Срок оценки: 20 days of treatment]
  • functional near-infrared spectroscopy [Срок оценки: 20 days of treatment]
Вторичные конечные точки (9)
  • scores of Montreal Cognitive Assessment Scale [Срок оценки: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]
  • scores of Positive and Negative Syndrome Scale [Срок оценки: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]
  • scores of Auditory Hallucinations Rating Scale [Срок оценки: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]
  • scores of Hamilton Anxiety Scale [Срок оценки: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]
  • scores of Hamilton Depression Scale [Срок оценки: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]
  • scores of Pittsburgh sleep quality index [Срок оценки: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]
  • The Clinical Assessment Interview for Negative Symptoms [Срок оценки: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]
  • Magnetic resonance imaging [Срок оценки: 1 day before the start of the treatment, 20 days of treatment]
  • Brain-derived neurotrophic factor [Срок оценки: 1 day before the start of the treatment, 20 days of treatment, 30 days after treatment]

Критерии участия

Критерии включения

  • Meets the diagnostic criteria for schizophrenia according to DSM-5.
  • Age ≥ 18 years old.
  • Right-handed.
  • Willing to participate in this study and sign an informed consent form. If the participant is unable to read and sign the informed consent form due to lack of capacity, a legal guardian must act as a proxy during the informed consent process and sign the form.
  • Clinically stable, receiving antipsychotic medication treatment with a stable dose for 4 weeks without any changes.
  • Montreal Cognitive Assessment score ≥ 10 points.

Критерии исключения

  • Psychotic disorders caused by split affective disorder, bipolar disorder, intellectual disability, anxiety spectrum disorders, drugs, alcohol, and other psychoactive substances according to DSM-V diagnostic criteria.
  • Those with severe or unstable organic diseases, with a history of brain tumors or epilepsy.
  • Those who have received MECT or TMS treatment within 1 month before enrollment.
  • Skin integrity at the electrode placement site is compromised. Allergy to electrode gel or adhesive.
  • Implants of metal or electronic devices (such as pacemakers, cochlear implants, deep brain stimulators, aneurysm clips, internal fixation devices after ventriculoperitoneal shunt surgery, etc.).
  • Participation in any other clinical trials within 1 month prior to baseline.
  • Pregnant and lactating women.
  • The investigator believes that there are inappropriate conditions for participating in this study.

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 · 2 центра
  • Sir Run Run Shaw Hospital — Hanzhou
  • Quzhou Third Hospital — Quzhou

Идентификаторы

NCT: NCT06470516 · 20230914

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗