跳至主要内容
临床试验/NCT07221110
NCT07221110已完成不适用

Effectiveness of Transcranial Magnetic Stimulation on Dysphagia in Patients With Parkinson's Disease: A Randomized Double-Blind Study

Ege University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
FEES evaluation

研究概览

简要总结

The study was conducted with patients with dysphagia who were followed up with Parkinson's disease in the neurology and physical therapy rehabilitation departments. The study is a prospective, double-blind clinical intervention study. Patients were divided into two groups (5 Hz and 10 Hz) and received rTMS (repetitive transcranial magnetic stimulation) treatment. The pharyngeal cortex region was targeted in the intervention. Major aim in the treatment was to examine the difference in clinical response caused by the application of rTMS treatment at different frequencies.

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
Single (Investigator)

盲法说明

there is no

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Parkinson's disease for more than two years
  • •Moderate-to-severe Parkinson's disease (Hoehn yahr 2-4)
  • •The patient describing dysphagia symptoms
  • •Patients being able to give informed consent.

排除标准

  • •İntracranial metallic device
  • •Cardiac pace-maker
  • •History of seizure
  • •İntracranial lesion on imaging
  • •Hydrocephalus
  • •Antipsychotic use
  • •Babinski positivity
  • •Berebellar symptoms
  • •Depression

研究组 & 干预措施

5 Hz

Experimental

Our patients in this arm will receive 10 sessions of treatment on the rTMS device. The device setting will be 5 Hz. All patients will also receive massako, shaker, triflo and cervical strengthening exercises. Our patients will be evaluated with FEES (Fiberoptic endoscopic swallowing evaluation) before, at the end of the treatment and at the 9th month controls in terms of the status of dysphagia.

干预措施: Repetitive Transcranial Magnetic Stimulation (Device)

5 Hz

Experimental

Our patients in this arm will receive 10 sessions of treatment on the rTMS device. The device setting will be 5 Hz. All patients will also receive massako, shaker, triflo and cervical strengthening exercises. Our patients will be evaluated with FEES (Fiberoptic endoscopic swallowing evaluation) before, at the end of the treatment and at the 9th month controls in terms of the status of dysphagia.

干预措施: Exercise (Other)

10 Hz

Experimental

Our patients in this arm will receive 10 sessions of treatment on the rTMS device. The device setting will be 10 Hz. All patients will also receive massako, shaker, triflo and cervical strengthening exercises. Our patients will be evaluated with FEES (Fiberoptic endoscopic swallowing evaluation) before, at the end of the treatment and at the 9th month controls in terms of the status of dysphagia.

干预措施: Repetitive Transcranial Magnetic Stimulation (Device)

10 Hz

Experimental

Our patients in this arm will receive 10 sessions of treatment on the rTMS device. The device setting will be 10 Hz. All patients will also receive massako, shaker, triflo and cervical strengthening exercises. Our patients will be evaluated with FEES (Fiberoptic endoscopic swallowing evaluation) before, at the end of the treatment and at the 9th month controls in terms of the status of dysphagia.

干预措施: Exercise (Other)

结局指标

主要结局

FEES evaluation

时间窗: until two weeks after the start of treatment

For the evaluation, a thin flexible nasopharyngoscope was passed through the nasal passage to visualize the pharynx and larynx. Food trials were performed for the swallowing assessment. For this purpose, patients were given water, nectar in volumes of 3-5-10-20 ml; 1 teaspoon (5 ml) of yogurt and 1 fish cracker. After the evaluation, early spillage, penetration, aspiration, and the presence/absence of residue in the pharyngeal wall/retrocricoid area/piriform sinus/vallekula were recorded. At the same time, the YALE-2016 vallekular residue scale, YALE-2016 piriform sinus residue scale, and penetration aspiration scale (PAS) scores were determined. YALE-2016 Vallekular/Piriform Sinus Residue Scale: This scale scores patients from 1 to 5 during flexible endoscopic examination based on the amount of residue in the vallekula and piriform sinus: none/trace/mild/moderate/severe. PAS: This scale rates patients from 1to5 based on aspiration/penetration and the presence of a protective reflex

Swallowing Assessment Form:

时间窗: up to two weeks after the start of treatment

The form records data on patients' age, gender, duration of Parkinson's disease, duration of dysphagia, history of pneumonia, Hoehn-Yahr stage, type of nutrition, dysphagia with solid food, dysphagia with semi-solid food, dysphagia with liquid food, sensation of food getting stuck in the throat, sensation of choking, and need to clear the throat.

Functional Oral Intake Scale (FOIS):

时间窗: until two weeks after the start of treatment

Oral intake in patients; no oral intake (1), minimal attempt at solid-liquid food, dependent on tube feeding (2), continuous solid and liquid oral intake, but dependent on tube feeding (3), total oral diet of uniform consistency (4), total oral diet of varying consistencies, but requiring special preparation or compensation (5), total oral diet of varying consistencies, not requiring special preparation, but with specific food limitations (6), total oral diet without restrictions (7).

Functional Swallowing Scale (FSS):

时间窗: until two weeks after the start of treatment

This scale assesses patients' daily dysphagia symptoms and associated weight loss. Patients are classified as normal function and asymptomatic (0), normal function with episodic or daily dysphagia symptoms (1), abnormal function compensated by significant dietary modifications (2), and abnormal function with decompensation, with \<10% weight loss in the last 6 months due to dysphagia or coughing/ choking/aspiration during daily meals (3), severe decompensated abnormal function with \>10% weight loss in the last 6 months due to dysphagia/severe aspiration/non-oral feeding for most foods (4), non-oral feeding for all foods (5).

Swallowing Function Screening Test (EAT-10):

时间窗: until two weeks after the start of treatment

An EAT-10 score of 3 or higher indicates abnormality. This test can be used to determine the initial severity of dysphagia in individuals with various swallowing disorders or to monitor treatment response.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kübra Efe

Doctor

Ege University

研究点 (1)

Loading locations...

相似试验

rTMS Treatment of Dysphagia in Parkinson's Patients | 临床试验