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Идёт набор NCT07113990

Electroacupuncture and rTMS for Post-Stroke Motor Recovery

Без фазы С лечением Stroke

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: Active EA, Sham EA, Active rTMS.
Кому может быть актуально
Состояния в реестре: Stroke. Базовые параметры: 40 лет — 75 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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Официальное название

Efficacy and Safety of Electroacupuncture Combined With rTMS on Motor Function Recovery After Stroke: A Multi-center Randomized Controlled Clinical Study

Обзор

This study aims to evaluate the combined efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) and Electroacupuncture (EA) in improving motor function recovery post-stroke, compared to rTMS combined with sham EA. Participants will receive either active EA or sham EA alongside standard rTMS treatment. Outcomes will be assessed using standardized clinical scales and neuroimaging techniques to explore underlying neuroplasticity mechanisms.

Подробное описание

Motor impairment is a major cause of disability following stroke, with central and peripheral neuromodulation strategies showing potential for functional recovery. Repetitive transcranial magnetic stimulation (rTMS) has been shown to promote neuroplasticity and enhance cortical excitability. Electroacupuncture (EA), by increasing somatosensory input, may further strengthen sensorimotor integration and cortical remodeling. However, limited clinical trials have systematically evaluated the synergistic effect of rTMS combined with EA.

This multi-center randomized controlled clinical study aims to assess the efficacy of combining rTMS and EA in improving motor function post-stroke. Outcome measures include clinical scales (FMA, ARAT, FAC), kinematic parameters, electrophysiological indices (EEG, EMG, TMS), blood biomarkers, and resting-state fMRI. The study is designed to explore central-peripheral neuroplasticity mechanisms and provide evidence for integrated rehabilitation approaches.

Вмешательства

  • Процедура Active EA
    Participants will receive electroacupuncture once daily for 2 consecutive weeks (total 10 sessions). Disposable sterile needles will be inserted at standardized acupoints to achieve de qi, then connected to an electroacupuncture device for 30 minutes per session.
  • Процедура Sham EA
    Participants will receive sham electroacupuncture once daily for 2 consecutive weeks (total 10 sessions). Disposable blunt needles will be placed at the same acupoints without skin penetration or electrical stimulation, with the electroacupuncture device turned on but delivering no current, for 30 minutes per session.
  • Устройство Active rTMS
    Participants will receive high-frequency rTMS to the ipsilesional M1 area once daily for 2 consecutive weeks (total 10 sessions). Stimulation will be delivered with a MagPro R30 stimulator at 10 Hz, 1600 pulses per session, 4-second trains with 41-second inter-train intervals.

Первичные конечные точки

  • Fugl-Meyer Assessment (FMA) [Срок оценки: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up]
Вторичные конечные точки (4)
  • Arm Research Action Test (ARAT) [Срок оценки: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up]
  • Functional Ambulation Classification (FAC) [Срок оценки: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up]
  • Modified Barthel Index (MBI) [Срок оценки: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up]
  • Stroke-Specific Quality of Life Scale (SS-QOL) [Срок оценки: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up]

Критерии участия

Критерии включения

  • Diagnosed with stroke confirmed by neuroimaging (CT/MRI).
  • First-ever stroke, unilateral hemispheric lesion, related to motor dysfunction.
  • Age between 40 and 75 years.
  • Duration from stroke onset between 2 weeks and 6 months.
  • Brunnstrom stage II-IV.
  • Right-handed.
  • Able to understand instructions and voluntarily provide written informed consent.

Критерии исключения

  • History of epilepsy or familial epilepsy.
  • Motor dysfunction due to non-vascular causes (e.g., tumor, trauma).
  • Severe aphasia or cognitive impairment (MoCA < 18).
  • Severe systemic complications (e.g., severe organ dysfunction, deep vein thrombosis).
  • Presence of metallic implants or contraindications for MRI.
  • Severe anxiety (HAMA > 7) or depression (HAMD > 8).
  • Severe spasticity (modified Ashworth ≥ 2).
  • Fear or intolerance of TMS or electroacupuncture.
  • Pregnancy, breastfeeding, or concurrent participation in other clinical trials affecting outcomes.

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 · 3 центра
  • Fuzhou University Affiliated Provincial Hospital — Фучжоу
  • Fujian Provincial People's Hospital — Фучжоу
  • Wenzhou Hospital of Traditional Chinese Medicine — Wenzhou

Идентификаторы

NCT: NCT07113990 · FujianUTCM-7

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗