Effect of Theta Burst Transcranial Magnetic Stimulation on Post-Stroke Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Standardized Swallowing Assessment
研究概览
简要总结
The purpose of this study was to observe the effect of Theta burst transcranial magnetic stimulation (TBS) on swallowing function in patients with dysphagia after stroke (PSD). Functional near- infrared spectroscopy (fNIRS) was used to detect the changes in activation and functional connectivity of related brain regions in PSD patients treated with intermittent TBS（iTBS）stimulation on the affected side and consistent TBS（cTBS） stimulation on the healthy side. To investigate the effects of TBS on swallowing related cortical excitability in stroke patients with dysphagia and explore its possible mechanism, and provide theoretical basis for the treatment of PSD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old
- •The first stroke lasted from 2 weeks to 6 months, with stable vital signs and right-handedness
- •The stroke met the diagnostic criteria of "Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage 2019" or "Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018" formulated by the Cerebrovascular Department of the Branch of Neurology of the Chinese Medical Association, and the cerebral CT or MRI examination showed unilateral cerebral infarction or cerebral hemorrhage.
- •The dysphagia was consistent with the Expert Consensus on the Evaluation and Treatment of dysphagia in China (2017 edition), and the dysphagia was confirmed by videofluoroscopic swallowing study.
- •MMSE>24, good cognitive function
- •The skull is intact without craniotomy or repair
- •Subject or family members sign informed consent
排除标准
- •Combined with other diseases that may cause swallowing disorders, such as Parkinson's disease, dementia, motor neurone disease and other neurological diseases, or esophageal, neck surgery and other diseases that cause swallowing organ structure abnormalities
- •A history of mental illness or epilepsy
- •A metal implant in the head or eye, a pacemaker or a drug pump in the body
- •Pregnancy, malignant tumor, serious disease history of heart, liver, kidney and other important organs
- •Ulceration or infection of the skin on the head or where the electrode is applied
- •Poor compliance and inability to complete basic treatment
结局指标
主要结局
Standardized Swallowing Assessment
时间窗: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.
The Standardized Swallowing Assessment scale is divided into three parts: clinical examination, water test, and normal eating, and is used to evaluate the safety and effectiveness of swallowing. The highest score of Standardized Swallowing Assessment scale is 46, and the lowest score is 18. The lower the score, the better the swallowing function.
Rosenbek Penetration-aspiration scale
时间窗: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.
The Rosenbek Penetration-aspiration scale assesses the patient's swallowing function by assessing the severity of penetration and aspiration. The results of Rosenbek Penetration-aspiration scale are divided into 8 grades from 1 to 8, and the lower the score, the better the swallowing ability.
functional near- infrared spectroscopy
时间窗: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.
fNIRS is a brain function detection technology, which can indirectly reflect the brain neural activity by detecting the content of oxygenated and deoxygenated hemoglobin in the cerebral cortex in real time. In this study, fNIRS was used to assess brain region activation and network connectivity characteristics during swallowing tasks.
次要结局
未报告次要终点
研究者
Zhang Xiaohui
sponsor
The First Affiliated Hospital of Zhengzhou University