Exploration of Repeated High-frequency Transcranial Magnetic Stimulation for the Treatment of Acute Phase Aphasia in Post-stroke Patients

Обзор

Stroke is currently an important cause of death and disability among adults worldwide, with acute ischemic stroke being the most common type of stroke, accounting for 69.6% -72.8% of new strokes in China. The time division of the acute phase generally refers to the onset time within 1-2 weeks. About 21-38% of stroke patients have post-stroke aphasia. Post stroke aphasia is usually an acquired language disorder caused by damage to the language functional areas of the dominant hemisphere, characterized by varying degrees of impairment in some or all language functions, including speaking, listening and understanding, paraphrasing, naming, reading, and calligraphy abilities. Rehabilitation treatment for cerebral infarction should be done early rather than late. Based on this, this study aims to explore transcranial magnetic stimulation therapy for post-stroke aphasia patients in the acute phase. By regulating the balance of cortical excitability on both sides of the healthy and affected areas, early speech function rehabilitation can be achieved, which is necessary for improving the quality of life of post-stroke aphasia patients

Подробное описание

Post stroke aphasia (PSA) is an acquired communication disorder caused by brain injury, characterized by various functional impairments such as self speech, repetition, naming, auditory comprehension, reading, and writing. PSA is one of the serious sequelae of stroke, which seriously affects the quality of life of patients. Early intervention in speech therapy can to some extent restore patients' functional communication abilities. Transcranial magnetic stimulation (TMS) is currently the most widely used non-invasive therapy. TMS can generate a magnetic field through the principle of magnetoelectric conversion, which can penetrate the skull and generate a super threshold current, allowing neurons in the target brain area to discharge. High frequency rTMS (generally frequency\>5HZ) is usually applied to the affected side, aiming to improve aphasia symptoms by directly promoting the excitability of the affected cortex.

The rehabilitation treatment for PSA patients often stabilizes within a few months after stroke, and early intervention may maximize potential benefits. At present, research on high-frequency rTMS is mostly limited to the subacute or chronic phase. Therefore, this study aims to explore a safe and effective TMS treatment method during the acute phase.

Вмешательства

• Устройство TMS
  Continuous high-frequency transcranial magnetic stimulation therapy Targeting the left M1 area, continuous high-frequency stimulation was performed at a frequency of 10Hz with 80-100% TEP for 5 minutes each time, twice a day for a total of 5 days
• Устройство TMS
  Consistent with the experimental group protocol, the magnetic stimulation probe is a false stimulation probe that only produces sound but does not actually produce stimulation

Первичные конечные точки

• BDAE Scale Score [Срок оценки: From before treatment to 1 month after treatment, a total of 3 time points]

Вторичные конечные точки (1)

• Electrophysiological measurement [Срок оценки: From before treatment to 1 month after treatment, a total of 3 time points]

Критерии участия

Inclusion Criteria:1) Age ≥ 18 years old 2) Head MR confirms new onset of cerebral infarction, and aphasia symptoms are caused by cerebral infarction 3) Patient's hospitalization history is within 7 days 4) Can cooperate to complete all required inspection items and scales 5) Sign informed consent form 6) Right handed -

Exclusion Criteria:1)Patients with aphasia caused by non cerebral infarction,2) Non acute phase cerebral infarction patients with a course of more than 7 days 3) Severe neurological disorders other than stroke, such as epilepsy and hemorrhagic stroke, are combined 4) Patients with poor general condition and unable to complete relevant examinations and scale scores, such as patients with malignant arrhythmia, tumor, severe infection, malignant hypertension, diabetes hyperosmolar coma, etc 5) Previous or current comorbidities of severe mental illnesses, such as depression, schizophrenia, etc 6) Patients who have previously or currently taken sedatives or large amounts of sleep aids 7) Contraindications for combined transcranial magnetic stimulation: presence of metal or other implants (such as pacemakers) in the body 8) Pregnancy and lactation period

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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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Chongqing Medical University — Чунцин

Идентификаторы

NCT: NCT06787508 · 2024-335-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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