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Идёт набор NCT06933537

Effectiveness of Personalized Alternating Current Stimulation for Treating Emotional Disorders in CNS Demyelination Patients

Без фазы С лечением Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System

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: Neuroelectrics StarStim 32, Neuroelectrics StarStim 32.
Кому может быть актуально
Состояния в реестре: Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System. Базовые параметры: 18 лет — 65 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

This Study is Designed to Evaluate the Efficacy of Personalized Alternating Current Stimulation in the Treatment of Emotional Disorders in Patients With Inflammatory Demyelination of the Central Nervous System

Обзор

This study is designed to evaluate the efficacy of personalized alternating current stimulation in the treatment of emotional disorders in patients with inflammatory demyelination of the central nervous system.

Вмешательства

  • Устройство Neuroelectrics StarStim 32
    Using the advanced Neuroelectrics StarStim 32 device from Spain, individualized imaging modeling systems are employed to precisely target the frontal cortex. Personalized EEG-guided electrical stimulation protocols are selected. The stimulation parameters are as follows: a current intensity of 2 mA, a duration of 21 minutes per session, once daily for five consecutive days, with EEG monitoring conducted before and after electrical stimulation.
  • Устройство Neuroelectrics StarStim 32
    Sham stimulation is performed using the same device and procedures as the neuromodulation group. The stimulator automatically shuts off after 30 seconds, while maintaining the device's connection. This design creates an initial sensation similar to actual stimulation while preserving the double-blind nature of the study.

Первичные конечные точки

  • HAMA (Hamilton Anxiety Rating Scale) [Срок оценки: From enrollment to the end of treatment at 1month]
  • HADS (Hospital Anxiety and Depression Scale) [Срок оценки: From enrollment to the end of treatment at 1month]
  • SPS (Social Phobia Scale) [Срок оценки: From enrollment to the end of treatment at 1month]
  • PSWQ (Penn State Worry Questionnaire) [Срок оценки: From enrollment to the end of treatment at 1month]
Вторичные конечные точки (12)
  • EDSS (Expanded Disability Status Scale) [Срок оценки: From enrollment to 1 month later]
  • FSS (Fatigue Severity Scale) [Срок оценки: From enrollment to 1 month later]
  • HAMD (Hamilton Depression Rating Scale) [Срок оценки: From enrollment to 1 month later]
  • MMSE (Mini-Mental State Examination) [Срок оценки: From enrollment to 1 month later]
  • MoCA (Montreal Cognitive Assessment) [Срок оценки: From enrollment to 1 month later]
  • SDMT (Symbol Digit Modalities Test) [Срок оценки: From enrollment to 1 month later]
  • DST (DigiScan Test) [Срок оценки: From enrollment to 1 month later]
  • BVMT (Brief Visuospatial Memory Test) [Срок оценки: From enrollment to 1 month later]
  • NRS (Numerical Rating Scale) [Срок оценки: From enrollment to 1 month later]
  • SF-MPQ (Short-Form McGill Pain Questionnaire) [Срок оценки: From enrollment to 1 month later]
  • ESS (Epworth Sleepiness Scale) [Срок оценки: From enrollment to 1 month later]
  • Ashworth Scale [Срок оценки: From enrollment to 1 month later]

Критерии участия

Критерии включения

  • Patients diagnosed with inflammatory demyelinating diseases of the central nervous system, such as neuromyelitis optica spectrum disorders (NMOSD) and multiple sclerosis (MS)
  • Hamilton Anxiety Scale (HAM-A) score > 14
  • Aged between 18 and 65 years, with no gender restrictions
  • Receiving stable doses of immunosuppressive therapy for at least one month
  • Expanded Disability Status Scale (EDSS) score ≤ 6
  • Right-handed
  • Willing to participate and sign informed consent

Критерии исключения

  • Recorded relapse within the past month
  • Recent medication adjustments or treatments involving modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques within the past month
  • Participation in any other clinical study within the past month or currently
  • Presence of cochlear implants, cardiac pacemakers, or implanted stimulators in the brain
  • Impaired skin integrity at the electrode placement site or allergies to electrode gel or adhesives
  • History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections
  • Pregnant or breastfeeding women, or those planning to conceive in the near future
  • Hamilton Depression Scale suicide item score ≥ 3 or comorbid severe mental disorders
  • Presence of severe or unstable organic diseases
  • Poor compliance preventing cooperation with treatment, follow-up, or clinical, EEG, and imaging data collection
  • Any condition deemed unsuitable for study participation by the investigator

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: NCT06933537 · xw-tES-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗