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Набор скоро начнётся NCT07491029

AI-based Customized tDCS for Finger Motor Recovery After Subacute Stroke

Без фазы С лечением Subacute Stroke Upper Extremity 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: AI-based Customized transcranial Direct Current Stimulation, Sham transcranial Direct Current Stimulation.
Кому может быть актуально
Состояния в реестре: Subacute Stroke, Upper Extremity Function. Базовые параметры: от 19 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
South Korea
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

A Multi-center, Randomized, Double-blind, Prospective, Superiority Clinical Trial to Evaluate the Safety and Effectiveness of Artificial Intelligence-based Customized Transcranial Direct Current Stimulation Using MR Images for Improving Finger Motor Function in Patients With Finger Paralysis Due to Subacute Stroke

Обзор

The goal of this clinical study is to evaluate whether AI-based customized transcranial direct current stimulation (tDCS) using MR images is more effective than sham stimulation in improving finger motor function in patients with finger paralysis caused by subacute stroke. The main questions it aims to answer are: * Does AI-based customized tDCS improve finger motor function compared with sham stimulation? * What medical problems or adverse events occur when participants receive AI-based customized tDCS? Researchers will compare AI-based customized tDCS with sham stimulation (a look-alike stimulation that delivers no electrical current) to determine whether the intervention improves finger motor recovery in patients with subacute stroke.

Вмешательства

  • Устройство AI-based Customized transcranial Direct Current Stimulation
    Transcranial direct current stimulation (2 mA for 30 minutes) will be delivered using electrode positions optimized by an AI-based simulation based on each participant's MR images to target the motor cortex.
  • Устройство Sham transcranial Direct Current Stimulation
    Transcranial direct current stimulation (0 mA for 30 minutes) will be delivered using electrode positions optimized by an AI-based simulation based on each participant's MR images.

Первичные конечные точки

  • Fugl-Meyer Function Test [Срок оценки: Baseline, At 2 weeks from baseline]
Вторичные конечные точки (7)
  • Fugl-Meyer Function Test [Срок оценки: Baseline, At 1, 3, 4, 14 weeks from baseline]
  • Wolf Motor Function Test [Срок оценки: Baseline, At 1, 2, 3, 4, 14 weeks from baseline]
  • Box and Blocks Test [Срок оценки: Baseline, At 1, 2, 3, 4, 14 weeks from baseline]
  • Korean version of Modified Barthel Index (K-MBI) [Срок оценки: Baseline, At 1, 2, 3, 4, 14 weeks from baseline]
  • Grip Strength [Срок оценки: Baseline, At 1, 2, 3, 4, 14 weeks from baseline]
  • EuroQol 5-Dimension 5-Level (EQ-5D-5L) [Срок оценки: Baseline, At 2, 14 weeks from baseline]
  • Motor-Evoked Potential (MEP) [Срок оценки: Baseline, At 2 weeks from baseline]

Критерии участия

Критерии включения

Participants must meet all of the following criteria to be eligible for this clinical trial:

  • Adults aged 19 years or older
  • Patients with stroke confirmed by brain imaging
  • Subacute stroke patients within 2 weeks to 3 months after stroke onset
  • Patients with unilateral upper-extremity paralysis
  • Upper-extremity Fugl-Meyer Assessment (FMA-UE, maximum score 66) score between 20 and 56
  • Participants who voluntarily provide written informed consent after receiving and understanding the study procedures and requirements

Критерии исключения

Participants will be excluded if they meet any of the following criteria:

  • History of a condition affecting the function of the paralyzed arm
  • Inability to follow instructions or complete the study due to cognitive impairment or aphasia
  • Evidence of delirium, confusion, or other disorders of consciousness
  • Presence of uncontrolled medical or surgical conditions
  • Severe neurological disorders associated with major psychiatric conditions (e.g., major depressive disorder, schizophrenia, bipolar disorder, or dementia)
  • History of uncontrolled epilepsy (seizure disorder)
  • Contraindications to transcranial direct current stimulation (tDCS), including:
  • Scalp disease or metal materials at the electrode attachment site
  • Presence of a cardiac pacemaker or cochlear implant
  • Medical contraindications to MRI examination
  • Pregnant or breastfeeding women, or those planning pregnancy during the study period
  • Use of a stimulation device similar to the investigational device or participation in a related clinical study within the past 1 year
  • Individuals judged by the investigator to be medically or ethically unsuitable for participation in this clinical 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

South Korea · 1 центр
  • Severance Hospital — Seoul

Идентификаторы

NCT: NCT07491029 · 1-2025-0078

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗