Scalp Acupuncture Combined With rTMS for Upper Limb Motor Dysfunction in Stroke: A Brain Network Study

Официальное название

Research Protocol for a Randomized Controlled Trial on Brain Network Study of Upper Limb Motor Dysfunction in Stroke Patients Treated With Scalp Acupuncture Combined With rTMS

Обзор

This study aims to compare the improvement effects of the rTMS (repetitive transcranial magnetic stimulation) combined with conventional rehabilitation therapy group with the rTMS combined with scalp acupuncture and conventional rehabilitation therapy group. Through statistical analysis of the results obtained from functional near-infrared spectroscopy technology during task states, the investigators elucidate the neuroregulatory mechanism of scalp acupuncture combined with rTMS in improving upper limb motor function in stroke patients under MEP localization, and provide evidence for a more optimal rehabilitation program for post-stroke upper limb motor dysfunction.

Вмешательства

• Устройство Repetitive transcranial magnetic stimulation
  Transcranial magnetic stimulation applied a figure-8 coil to the premotor area at 80%-100% of the healthy-side MEP threshold. Treatment lasted 20 min in two phases: weeks 1-2 on the ipsilateral M1 (1Hz, 10s on/5s off), and weeks 3-4 on the contralateral M1 (10Hz, 3s on/12s off). Treat once a day, 5 days a week, for a total of 4 weeks.
• Процедура Scalp acupuncture
  Scalp acupuncture selected bilateral upper-limb cortical MEP points (2 points total). The healthy-side hot spot was identified first; if the affected side had no MEP, its mirror point was used. Needles were inserted from point A (affected) to B (healthy) and beyond along the AB line. After insertion, needles were rotated for 2-3 min, manipulated every 10 min, and retained for 30 min. Treat once a day, 5 days a week, for a total of 4 weeks.
• Комбинированный продукт Conventional rehabilitation treatment
  Conventional drug therapy included secondary stroke prevention, neurotrophy, and improved cerebral circulation. Routine rehabilitation involved exercise, occupational, and physical therapies, with a total daily treatment time of 90 minutes.

Первичные конечные точки

• Maximum amplitude of motor evoked potential [Срок оценки: One day before treatment, four weeks after treatment]
• Fugl-Meyer Assessment-Upper Extremities [Срок оценки: One day before treatment, four weeks after treatment]

Вторичные конечные точки (3)

• Action Research Arm Test [Срок оценки: One day before treatment, four weeks after treatment]
• Modified Barthel Index [Срок оценки: One day before treatment, four weeks after treatment]
• Functional near-infrared spectroscopy [Срок оценки: One day before treatment, two weeks after treatment, four weeks after treatment]

Критерии участия

Критерии включения

• Meet the diagnostic criteria for stroke (symptoms and signs, imaging indicators, etc.), and are independently diagnosed by two deputy chief physicians
• Age 18-70 years old, first episode, duration 1-6 months
• The diagnostic criteria for upper limb dysfunction align with the Brunnstrom staging system: patients in Brunnstrom stages II to IV. Stage II: patients exhibit associative responses and can perform coordinated movements, with minimal voluntary movements; Stage III: patients show voluntary coordinated movements, such as grasping with the hand but not extending; Stage IV: patients can perform isolated movements, such as pinching with the hand and limited extension
• No severe visual or hearing impairment, able to cooperate with relevant assessments and tests
• The score of the Mini-Mental State Examination is ≥20 points
• Vital signs are stable, with no signs of progressive neurological symptoms
• The patient or legal guardian agrees and signs the informed consent form

Критерии исключения

• Severe visual impairment, hemispatial neglect, body image disorder
• Individuals who cannot undergo rTMS treatment due to reasons such as metal implants, cardiac pacemakers, or skull defects
• Previous history of brain tumor, brain trauma, epilepsy, and risk of epileptic seizures
• Any other factors that affect assessment and treatment
• Dysfunction of limb movement caused by other reasons (such as trauma, etc.)

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 · 1 центр

• the Third Affiliated Hospital of Zhejiang Chinese Medical University — Ханчжоу

Публикации

• Kong D, Huang X, Zhang S, Chen K, Gao H, Xie H. MEP-Guided Scalp Acupuncture Combined with Repetitive Transcranial Magnetic Stimulation for Post-Stroke Upper Extremity Motor Impairment: A Randomized Controlled Study Protocol. Int J Gen Med. 2026 Feb 24;19:582719. doi: 10.2147/IJGM.S582719. eCollection 2026. PMID 41769053

Идентификаторы

NCT: NCT07210944 · ZSLL-KY-2025-046

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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