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Набор скоро начнётся NCT06904092

Efficacy and Mechanisms of TUS on Cognitive Deficits in Schizophrenia: Based on the Hippocampal-Prefrontal Circuit

Без фазы С лечением Cognitive Deficit in 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: Transcranial ultrasound stimulation.
Кому может быть актуально
Состояния в реестре: Cognitive Deficit in Schizophrenia. Базовые параметры: 18 лет — 50 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
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Официальное название

Efficacy and Mechanisms of Transcranial Ultrasound Stimulation (TUS) on Cognitive Deficits in Schizophrenia：Based on the Hippocampal-Prefrontal Circuit

Обзор

Cognitive deficit is a core symptom of schizophrenia related to poorer functional outcome. Prior studies indicated that abnormalities in the hippocampus-prefrontal circuit and glutamate/GABA imbalances may lead to cognitive deficits. Based on the current background and our previous studies, it has been proved that TUS can modulate neural excitability and plasticity in the hippocampus. In this double-blind, randomized study, the efficacy of different treatment options and mechanisms of TUS on cognitive deficits will be investigated.

Подробное описание

Cognitive deficit is a core symptom of schizophrenia related to poorer functional outcome which remains largely treatment refractory. Prior studies indicated that abnormalities in the hippocampus-prefrontal circuit and glutamate/GABA imbalances may be the root causes of cognitive deficits. Transcranial ultrasound stimulation (TUS), an emerging non-invasive neuromodulation technique with deep penetration ability, can modulate neural excitability and plasticity in the hippocampus. This is a 4-week double-blind randomized trial of TUS for cognitive deficits in schizophrenia, with either left hippocampus or left dorsolateral prefrontal cortex (DLPFC) or both targeted. This study aims to determine the efficacy of TUS and to reveal its underlying neural mechanism, especially with the hippocampus-prefrontal circuit, by means of TUS, as to assess cortical inhibition and excitability, EEG source imaging, and multi-model MRI. Neuropsychological assessments will also be conducted to develop the optimized treatment strategy. The study points to a novel and promising therapeutic neuromodulation approach that may improve the functional outcome of schizophrenia, which has been the main cause of mental disability.

Вмешательства

  • Устройство Transcranial ultrasound stimulation
    The TUS was administered using Transcranial Ultrasound Stimulator UNS-III (model UNS-III), which has passed the safety test for medical electrical equipment (GB9706.1-2007). Transcranial ultrasound stimulation on the target. Duration:20 days (workdays for four consecutive weeks).

Первичные конечные точки

  • Change from baseline in associative memory test score [Срок оценки: baseline, 4 weeks and 8 weeks]
Вторичные конечные точки (8)
  • Change of information processing speed and attention/vigilance [Срок оценки: baseline, 4 weeks and 8 weeks]
  • Change of working memory [Срок оценки: baseline, 4 weeks and 8 weeks]
  • Change from baseline in Positive and Negative Syndrome Scale(PANSS) [Срок оценки: baseline, 4 weeks and 8 weeks]
  • Change of CGI score [Срок оценки: baseline, 4 weeks and 8 weeks]
  • Change of Multi-modal Brain Neuroimaging in structure [Срок оценки: baseline and 4 weeks]
  • Change of Multi-modal Brain Neuroimaging in resting- state fMRI [Срок оценки: baseline and 4 weeks]
  • Change of Multi-modal Brain Neuroimaging in 1H-MRS [Срок оценки: baseline and 4 weeks]
  • Change of 64 channels EEG [Срок оценки: baseline and 4 weeks]

Критерии участия

Критерии включения

  • Meet the DSM-5 diagnostic criteria for schizophrenia ;
  • Age18-50, right-handed, Han nationality;
  • Presence of cognitive deficit: defined as d' value <0.5 in associative memory test;
  • Be in a stable condition, received second-generation antipsychotics for at least 4 weeks or more;
  • Written informed consent;

Критерии исключения

  • Current or past neurological illness, severe physical diseases, substance abuse or alcohol dependence, mental retardation, pregnancy or lactation;
  • Uncooperative or risky patients with high excitement, stupor, disorder of words and deeds, negative suicide, etc.;
  • History of MECT or other physical therapy within 6 months;
  • History of epilepsy, or epileptic waves on the baseline EEG;
  • Ruled out share antiepileptic drugs (carbamazepine, valproic acid salt) or larger doses of benzodiazepine drugs (diazepam > 10mg/day, clonazepam > 2mg/day etc.), if necessary, remain unchanged during the course of treatment;
  • Contraindications to TUS and MRI are present.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai Mental Health Center — Шанхай

Идентификаторы

NCT: NCT06904092 · 82371504

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗