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Идёт набор NCT07087873

Assessment of Transcranial Alternating Current Stimulation's Clinical Efficacy in Treating Cognitive Impairment of Idiopathic Inflammatory Demyelinating Diseases

Без фазы С лечением Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System MS (Multiple Sclerosis) NMOSD Acute Disseminated Encephalomyelitis

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: Neuroelectrical modulation group, Pseudo-neuromodulation group.
Кому может быть актуально
Состояния в реестре: Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System, MS (Multiple Sclerosis), NMOSD, Acute Disseminated Encephalomyelitis. Базовые параметры: 18 лет — 60 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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Обзор

This study aims to explore the imaging and electrophysiological characteristics of idiopathic inflammatory demyelinating diseases (IIDDs), and their correlation with clinical manifestations. It also evaluates the effectiveness of transcranial electrical stimulation in alleviating clinical symptoms of IIDDs patients, and analyzes the key factors affecting the treatment efficacy. By uncovering the overall and individual characteristics of IIDDs, this study seeks to enhance therapeutic outcomes through personalized neuromodulation programs. The findings will provide a basis for applying non-invasive brain stimulation (NIBS) in IIDDs treatment and offer new ideas for future personalized medicine approaches.

Вмешательства

  • Устройство Neuroelectrical modulation group
    Participants received transcranial electrical stimulation using the Spanish Neuroelectrics StarStim 32 device.
  • Устройство Pseudo-neuromodulation group
    Pseudo-stimulation is performed using the same equipment and procedures as in the neuromodulation group.

Первичные конечные точки

  • Expanded Disability Status Scale, EDSS score [Срок оценки: At the 5-day point of treatment and 1 month following the end of treatment]
  • Symbol Digit Modalities Test (SDMT) scale [Срок оценки: At the 5-day point of treatment and 1 month following the end of treatment]
  • Scoring results for tasks 1 and 7 in the Alzheimer disease assessment scale-cog(ADAS-cog) [Срок оценки: At the 5-day point of treatment and 1 month following the end of treatment]
Вторичные конечные точки (6)
  • Mini-mental State Examination（MMSE） [Срок оценки: At the 5-day point of treatment and 1 month following the end of treatment]
  • Montreal-Cognitive Assessment（MoCA） [Срок оценки: At the 5-day point of treatment and 1 month following the end of treatment]
  • Stroop Color-Word Test score [Срок оценки: At the 5-day point of treatment and 1 month following the end of treatment]
  • Hamilton Depression Scale，HAMD [Срок оценки: At the 5-day point of treatment and 1 month following the end of treatment]
  • Hamilton Anxiety Scale，HAMA [Срок оценки: At the 5-day point of treatment and 1 month following the end of treatment]
  • a subjective questionnaire，adverse effects [Срок оценки: Following the first day of treatment，Following the second day of treatment，Following the third day of treatment，Following the fourth day of treatment，Following the fifth day of treatment]

Критерии участия

Критерии включения

  • Age: 18-60 years old.
  • Diagnosis: Patients with neuromyelitis optica spectrum disease, multiple sclerosis and other inflammatory demyelinating diseases of the central nervous system that meet the diagnostic criteria.
  • Medications have been stable for at least three months.

Критерии исключения

  • Recurrence has been recorded in the past 3 months.
  • Have a pacemaker or other metal implant in the body.
  • Impaired skin integrity at the site of electrode placement.
  • Previous organic brain disease such as epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infection.
  • Combined with severe or unstable organic diseases, such as heart, liver and kidney and other organ dysfunction.
  • Pregnant or lactating women, those who are planning to become pregnant in the near future.
  • Patient compliance is poor.
  • In the opinion of the investigator, there is a situation that is not suitable to participate 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 · 1 центр
  • Xuanwu Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07087873 · [2025]086-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗