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Идёт набор NCT07446478

TIS for Improving Cognitive Impairment Associated With Schizophrenia

Без фазы С лечением Cognitive Impairment Associated With Schizophrenia (CIAS)

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: temporal interference stimulation.
Кому может быть актуально
Состояния в реестре: Cognitive Impairment Associated With Schizophrenia (CIAS). 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 Safety of Time Interference Stimulation on Cognitive Impairment Associated With Schizophrenia

Обзор

This study aims to evaluate the efficacy and safety of TIS targeting the hippocampus in ameliorating cognitive impairment associated with schizophrenia (CIAS). Participants will receive TIS twice a day for 2 weeks. Their clinical data, including the baseline clinical symptom scale score, cognitive function, and MRI data, will be collected at baseline and at the end of the 2-week intervention.

Подробное описание

Cognitive impairment associated with schizophrenia (CIAS) remains a therapeutic challenge, as conventional antipsychotics and depth-limited neurostimulation (NIBS) fail to address the subcortical dysregulation that drives cognitive dysfunction. Temporal Interference Stimulation (TIS) overcomes these biophysical limitations by using intersecting high-frequency electric fields to non-invasively target deep structures such as the hippocampus with great spatial accuracy. Due to its potential to enhance the synchronization between the hippocampus and the prefrontal cortex, TIS offers a new prospect for treating CIAS.

This single-arm, open-label trial will evaluate the efficacy of hippocampal-targeted TIS in patients with schizophrenia. Participants will undergo a 10-day intervention (twice daily) and will be assessed using clinical, cognitive (MCCB), and neuroimaging (rs-fMRI) tests at baseline and post-intervention.

Вмешательства

  • Устройство temporal interference stimulation
    TIS will use 2 pairs of electrodes placed according to a 10-10 EEG system and fixed with conductive paste to produce a theta burst stimulation pattern. Electric field modeling will be performed utilizing MRI T1 images to optimize the individualized electrode configuration to generate electric field intensities above 0.6 V/m in the hippocampus of each patient. Each session of stimulation lasts 30 minutes.

Первичные конечные точки

  • changes on MCCB scores [Срок оценки: Baseline, after 2-week intervention]
Вторичные конечные точки (7)
  • Changes in Positive and Negative Symptom Scale (PANSS) scores [Срок оценки: Baseline, after 2-week intervention]
  • Change in Scale for Assessment of Negative Symptoms (SANS) score [Срок оценки: Baseline, after 2-week intervention]
  • Changes in Psychotic symptom rating scales (PSYRATS) score [Срок оценки: Baseline, after 2-week intervention]
  • Changes in brain function [Срок оценки: Baseline, after 2-week intervention]
  • changes on behavioral performance [Срок оценки: Baseline, after 2-week intervention]
  • changes of global function. [Срок оценки: Baseline, after 2-week intervention]
  • adverse event incidences [Срок оценки: Day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10.]

Критерии участия

Критерии включения

  • Age 18-50 years old;
  • meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnostic criteria;
  • the diagnosis of schizophrenia is confirmed by the Structured Clinical Interview for DSM-5 (SCID-5);
  • the disease duration does not exceed 8 years;
  • 1-2 antipsychotic drugs are taken, and the treatment dose of antipsychotic drugs was stable for at least 1 week before enrollment. Mood stabilizers, antidepressants, and excessive benzodiazepines (lorazepam when 2 doses exceeded 2 mg/d) are not allowed;
  • The type of antipsychotic drugs remains unchanged during treatment, and the dose is adjusted by no more than 25%;
  • Impaired functioning in daily activities;
  • The Global Deficit Score (GDS) for the MATRICS Consensus Cognitive Battery (MCCB) reaches 0.5 or above;
  • Agree to participate in this study and provide written informed consent

Критерии исключения

  • Presence of other psychiatric comorbidities, intellectual disability, obvious mood symptoms, or substance use disorders (other than caffeine and/or tobacco);
  • with clear drug-induced extrapyramidal reaction;
  • A history of seizures, meningitis, or encephalitis;
  • with contraindications to transcranial electrical stimulation;
  • History of intracranial tumors or surgery;
  • history of severe head trauma;
  • have received other regimens of electrical or magnetic therapy in 1 month before enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Second Xiangya Hospital, Central South University — Чанша

Идентификаторы

NCT: NCT07446478 · TIS20260106 · 82325020

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗