Effects of Healthy-side High-frequency Repetitive Transcranial Magnetic Stimulation in Patients With Post Stroke Dysphagia: a Prospective Study Based on Functional Near-infrared Spectroscopic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Standardized Swallowing Assessment
研究概览
简要总结
This trial was a randomized, double-blind, sham-controlled trial.Thirty patients with post-stroke dysphagia were randomly assigned to the repetitive transcranial magnetic stimulation(rTMS) group (n=15) or sham rTMS group (n=15). Both groups received conventional swallowing rehabilitation, and in addition, the rTMS group received 5hz repetitive transcranial magnetic stimulation on the healthy side. Swallowing function was assessed at admission and after two weeks of treatment using the the Standardized Swallowing Assessment (SSA), the Penetration-Aspiration Scale (PAS), the Fiberoptic Endoscopic Dysphagia Severity Scale(FEDSS), the Functional Oral Intake Scale (FOIS), and the functional near-infrared spectroscopic(fNIRS).
详细描述
Stroke is the leading cause of death and disability worldwide, and dysphagia is one of the common complications of stroke.Dysphagia after stroke can lead to serious complications such as aspiration, pneumonia, and malnutrition, which greatly reduces the quality of life of patients.Transcranial magnetic stimulation(TMS), a non-invasive central nervous system stimulation that is safe, non-invasive, and does not require active patient participation, has been gradually applied to stroke rehabilitation in recent years.Although there have been studies on the improvement of post stroke dysphagia(PSD) by healthy-side high-frequency rTMS, there have been no studies assessing the activation of relevant brain regions before and after its treatment by fNIRS and exploring the possible mechanisms involved. The aim of this study was to observe the effect of high-frequency rTMS stimulation of the healthy mandibular hyoid cortical area at 5 hz on PSD, and to explore the possible mechanisms by assessing it with fNIRS, so as to provide a theoretical basis for the clinical use of rTMS in the treatment of patients with PSD.
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
- •18 to 80 years of age, right-handed;
- •unilateral stroke, diagnosed by cranial MRI or CT;
- •disease duration of 2 weeks to 6 months;
- •dysphagia confirmed by the Videofluoroscopic swallowing study;
- •patient's vital signs were stable;
- •consciousness was clear, able to cooperate in completing the rehabilitation therapy, assessment, and the fNIRS test;
- •cranial bone was intact without craniotomy and/or craniovertebral repair;
- •the subject signed the Declaration of Helsinki according to the Informed consent.
排除标准
- •previous dysphagia due to other diseases such as Parkinson's disease, dementia, or the presence of organic swallowing dysfunction;
- •contraindications to rTMS: stimulation coils or the presence of a metal foreign body near the stimulated scalp, built-in pulse generators, cardiac stents, cardiac bypass grafting, etc;
- •previous history of psychiatric disease or epilepsy;
- •pregnancy;
- •skin infection or breakage on the head;
- •previous or current stroke, traumatic brain injury and other neurological or mental system diseases;
- •serious cardiac, pulmonary, hepatic, renal dysfunction, malignant tumors, serious complications;
- •poor patient compliance and evaluation,other neurological or psychiatric disorders;
- •severe cardiac, pulmonary, hepatic, or renal dysfunction, malignant tumors, and serious complications;
- •poor patient compliance and non-cooperation with treatment and evaluation.
结局指标
主要结局
Standardized Swallowing Assessment
时间窗: day 1 and day 14
SSA: consists of 3 parts, scoring 18-46 points: clinical evaluation, including consciousness, lip control and other seven items, total score 8-23 points; take about 5ml of water for the patient to swallow, repeat 3 times, the corner of the mouth with or without water, swallowing with or without laryngeal movement to observe the situation, the total score of 5-11 points; the first two items are normal, the amount of water was increased to about 60 ml, and whether the drink can be completed the whole situation, the total score of 5-12 points. The total score is 5\~12. The higher the score, the more serious the swallowing disorder.
次要结局
- Functional Oral Intake Scale(day 1 and day 14)
- Fiberoptic Endoscopic Dysphagia Severity Scale(day 1 and day 14)
- Functional near-infrared spectroscopy(day 1 and day 14)
- Penetration-Aspiration Scale(day 1 and day 14)
研究者
Ruyao Liu
Principal Investigator
The First Affiliated Hospital of Zhengzhou University