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临床试验/NCT04308733
NCT04308733Unknown不适用

Transcranial Direct Current Stimulation (tDCS) for Patients With Oro-pharyngeal Dysphagia Associated to Brainstem Stroke

Presidio Ospedaliero Garibaldi-Centro2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年3月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Penetration Aspiration Scale (PAS)

研究概览

简要总结

The aim of the study is to investigate the effect of anodal transcranial direct current stimulation applied over the pharyngeal motor area in 60 dysphagic patients with acute isolated brainstem stroke. Thirty patients will undergo stimulation on the pharyngeal area contralateral to the side of brainstem lesion, and 30 patients will receive sham stimulation over the contralateral area, for 4 consecutive days. Patients will be re-evaluated after 4 consecutive days of stimulation. Primary outcome: The Penetration/Aspiration Scale after 4 consecutive days of stimulation. Secondary outcomes: changes in electromyographic parameters and pharyngeal cortical motor evoked potentials, changes in the Dysphagia Severity Rating Scale (DSRS), in the Functional Oral Intake Scale (FOIS), and in the "Dysphagia Limit Test", after 4 consecutive days of stimulation.

详细描述

Sixty consecutive patients with dysphagia associated to isolated acute (within the previous 24 hours) brainstem ischemic stroke satisfying the inclusion/exclusion criteria will be enrolled.

Swallowing evaluation Clinical evaluation comprises fiberoptic endoscopy that will be used for scoring the Penetration/Aspiration Scale. The Penetration/Aspiration Scale will be scored by two otolaryngologists and one neurologist blinded to the patient's study group allocation. Moreover, feeding status will be evaluated by the clinical "Dysphagia Severity Rating Scale", ranging from 0 (normal fluids, normal diet, and eating independently) to 12 (no oral fluids, no oral feeding). Moreover the "Functional Oral Intake Scale", ranging from 1 (nothing by mouth) to 7 (total oral diet with no restriction), and the "Dysphagia Limit Test", evaluating the amount of water that can be swallowed without piece-meal deglutition or clinical signs of aspiration, will be used in patient evaluation. Piecemeal deglutition will be evaluated both clinically and by means of electromyographic recordings from the mouth floor muscles. Moreover, simultaneous electromyographic/mechanographic recordings from the above mentioned muscles, as well as from cricopharyngeal muscle and from the thyroid cartilage will be also performed. The changes in cortico-pharyngeal excitability will be evaluated by recording motor evoked potentials from the pharyngeal muscles after transcranial magnetic stimulation.

Randomization: patients will be randomly assigned to either the active treatment (real) or sham groups according to a computer-generated list. Randomization will be stratified in order to match age, and severity of dysphagia.

Transcranial direct current stimulation: anodal transcranial direct current stimulation will be delivered through two 25-cm2 rectangular surface electrodes, with the active one placed over the "pharyngeal" area of the motor cortex contralateral to the side of brainstem lesion and the reference one on the contralateral supraorbital ridge. Furthermore, the electrodes will be fixed in their position using a set of adjustable rubber straps placed around the head. For the active intervention (the "real" stimulation group), current intensity will be slowly increased up to 2mA. This intensity will be maintained for 20 min before the stimulation will be slowly turned off over a 10-sec period. For the "sham" intervention, the current will be left on only for 30 sec, while the electrodes will be left in place for a further 20-min period. All patients will be evaluated at baseline, and after 4 consecutive days of stimulation.

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 (Participant)

盲法说明

double-blind

入排标准

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

入选标准

  • accepting to participating to the study
  • age not < 18 years
  • bulbar stroke occurring within the previous 24 hours

排除标准

  • age < 18 years
  • inability to give informed consent because of cognitive impairment
  • stroke occurring over the previous 24 hours

结局指标

主要结局

Penetration Aspiration Scale (PAS)

时间窗: Change from baseline PAS at 4 days

PAS is an 8-point severity scale from 1 = no material enters the airways to 8 = material enters the airways, passes below the vocal folds in the absence of any effort to eject it.

次要结局

  • Dysphagia Limit Test(Change from baseline "Dysphagia Limit Test" at 4 days)
  • Functional Oral Intake Scale (FOIS)(Change from baseline FOIS at 4 days)
  • Pharyngeal (motor evoked potentials (MEPs) after Transcranial Magnetic Stimulation (TMS)(Change from baseline pharyngeal MEPs at 4 days)
  • electromyographic/cinematic evaluation of swallowing(Change from baseline electromyographic/cinematic parameters at 4 days)

研究者

发起方
Presidio Ospedaliero Garibaldi-Centro
申办方类型
Other
责任方
Principal Investigator
主要研究者

Domenico Antonio Restivo

Consutant Neurologist

Presidio Ospedaliero Garibaldi-Centro

研究点 (2)

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