Repetitive Transcranial Magnetic Stimulation in Cardiac Autonomic Dysfunction
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: rTMS M1 Motor Cortex Protocol, Sham rTMS Protocol.
- Кому может быть актуально
- Состояния в реестре: Stroke, Autonomic Dysfunction, Hemiparesis. Базовые параметры: 35 лет — 80 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
- Turkey (Türkiye)
- 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
The Effect of Repetitive Transcranial Magnetic Stimulation on Cardiac Autonomic Dysfunction in Patients With Stroke
Обзор
The aim of this study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) added to conventional neurological rehabilitation on heart rate variability (HRV), quality of life, upper extremity muscle strength and autonomic symptoms in patients with stroke.
Подробное описание
Stroke is a leading cause of disability worldwide and is frequently associated with autonomic dysfunction (AD). AD can affect heart function, arterial blood pressure, fluid balance, and other body systems, negatively influencing clinical outcomes and prognosis. Brain damage in cortical and subcortical regions during stroke can disrupt the integrity of the central autonomic network, leading to AD. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method thought to support neuroplasticity and potentially improve autonomic function. This study aims to investigate the effects of rTMS on autonomic dysfunction and related functional parameters in patients with stroke.
Вмешательства
- Устройство rTMS M1 Motor Cortex Protocol
Repetitive transcranial magnetic stimulation (rTMS) will be applied using the MagVenture MagPro R30 device with a Figure Eight Coil according to the study protocol. rTMS will be delivered to the contralateral primary motor cortex (M1) upper extremity motor area at a low frequency of 1 Hz, 5 sessions per week for 4 weeks, totaling 20 sessions. - Устройство Sham rTMS Protocol
Sham (placebo) repetitive transcranial magnetic stimulation (rTMS) will be applied to mimic the procedure without delivering active stimulation. It was planned to apply it daily for 20 sessions.
Первичные конечные точки
- Change from Baseline in Heart Rate Variability (HRV) Assessment at the 4th week [Срок оценки: Baseline and after final rTMS session( at 4th week)]
Вторичные конечные точки (6)
- Change from baseline in Brunnstrom Stage Assessment at the 4th week [Срок оценки: Baseline and after final rTMS session( at 4th week)]
- Change from baseline in Modified Ashworth Scale (MAS) Assessment at the 4th week [Срок оценки: Baseline and after final rTMS session( at 4th week)]
- Change from baseline in Stroke-Specific Quality of Life Scale (SSQOL) at the 4th week [Срок оценки: Baseline and after final rTMS session( at 4th week)]
- Change from baseline in Grip Strength at the 4th week [Срок оценки: Baseline and after final rTMS session( at 4th week)]
- Change from baseline in Composite Autonomic Symptom Score 31(COMPASS 31) Scoring Test at the 4th week [Срок оценки: Baseline and after final rTMS session( at 4th week)]
- Change from baseline in Blood Pressure Measurement at the 4th week [Срок оценки: Baseline and after final rTMS session( at 4th week)]
Критерии участия
Критерии включения
- Participants aged 35-80 years admitted to the Afyonkarahisar Health Sciences University Hospital Physical Medicine and Rehabilitation Unit for neurological rehabilitation after stroke
- Participants with a history of stroke of at least 3 months
- Neurologically and medically stable participants willing to participate regularly in the study
- Participants capable of following commands
Критерии исключения
- Serious cardiac disease, uncontrolled hypertension
- Epilepsy or history of antiepileptic drug use
- Intracranial metallic implants
- Inner ear implants
- Malignancy
- Active infection
- Skin infection or open wound in the intervention area
- Brain lesions or medications that may alter the seizure threshold
- Increased intracranial pressure
- Uncontrolled migraine
- Fracture or surgery on the hemiplegic side within the last 6 months
- Pregnancy
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
Turkey (Türkiye) · 1 центр
- Afyonkarahisar Health Science University — Afyonkarahisar
Публикации
- Yoshida T, Yoshino A, Kobayashi Y, Inoue M, Kamakura K, Nomura S. Effects of slow repetitive transcranial magnetic stimulation on heart rate variability according to power spectrum analysis. J Neurol Sci. 2001 Feb 15;184(1):77-80. doi: 10.1016/s0022-510x(00)00505-0. PMID 11231036
- Udupa K, Sathyaprabha TN, Thirthalli J, Kishore KR, Raju TR, Gangadhar BN. Modulation of cardiac autonomic functions in patients with major depression treated with repetitive transcranial magnetic stimulation. J Affect Disord. 2007 Dec;104(1-3):231-6. doi: 10.1016/j.jad.2007.04.002. Epub 2007 May 8. PMID 17490754
- Cabrerizo M, Cabrera A, Perez JO, de la Rua J, Rojas N, Zhou Q, Pinzon-Ardila A, Gonzalez-Arias SM, Adjouadi M. Induced effects of transcranial magnetic stimulation on the autonomic nervous system and the cardiac rhythm. ScientificWorldJournal. 2014;2014:349718. doi: 10.1155/2014/349718. Epub 2014 Jul 17. PMID 25136660
Идентификаторы
NCT: NCT07482501 · TMSCAD2026