The goal of this clinical trial is to evaluate whether the application of optimized transcranial direct current stimulation is more effective compared to sham stimulation for temporary improvement of swallowing function in patients with post-stroke dysphagia.
men and women >19 years old
patients with stroke confirmed by neuroimaging
first-time stroke patients
patients in subacute or chronic phases of stroke with 3 weeks or more after onset
patients with recurrent stoke, traumatic brain injury, spine cord injury, and degenerative brain disease, such as Parkinson's disease, etc.
patients with deteriorated cognitive function unable to perform the clinical trial as instructed
patients with evidence of delirium, confusion, or other impairment of consciousness
patients with uncontrolled medical disease or surgical conditions
Parallel
Optimized transcranial Direct Current Stimulation
Devicetranscranial Direct Current Stimulation 2mA for 30 min; The anode electrode will be located over the contralesional representation of the motor cortex swallowing area, while the cathode electrode will be positioned on the ipsilesional side
Sham transcranial Direct Current Stimulation
Devicetranscranial Direct Current sham Stimulation for 30 min; The anode electrode will be located over the contralesional representation of the motor cortex swallowing area, while the cathode electrode will be positioned on the ipsilesional side
Functional Oral Intake Scale (FOIS)
FOIS is a scale used for purposes to assess changes in functional oral intake of food and liquids in patients with dysphagia. FOIS is sensitive to changes in oral intake of food and liquid over time in stroke patients. The scale ranges from level 1 (nothing by mouth) to level 7 (a full unrestricted oral diet)
Penetration-aspiration Scale (PAS)
PAS is a standard scale to assess deglutition in clinical practice and research. It is composed of an 8-point scale used to characterize both the location of airway invasion events and patient's response during video fluoroscopic swallowing studies. The scale design to capture three constructs: depth of airway invasion, material remaining after swallow, and patient's response to aspiration. The scale ranges from score 1 (Material does not enter the airway) to score 8 (Material enters the airway, passes below the level of the vocal folds, and no effort is made to eject)
Functional Oral Intake Scale (FOIS)
FOIS is a scale used for purposes to assess changes in functional oral intake of food and liquids in patients with dysphagia. FOIS is sensitive to changes in oral intake of food and liquid over time in stroke patients. The scale ranges from level 1 (nothing by mouth) to level 7 (a full unrestricted oral diet)
Penetration-aspiration Scale (PAS)
PAS is a standard scale to assess deglutition in clinical practice and research. It is composed of an 8-point scale used to characterize both the location of airway invasion events and patient's response during video fluoroscopic swallowing studies. The scale design to capture three constructs: depth of airway invasion, material remaining after swallow, and patient's response to aspiration. The scale ranges from score 1 (Material does not enter the airway) to score 8 (Material enters the airway, passes below the level of the vocal folds, and no effort is made to eject)
Videofluoroscopic Dysphagia Scale (VDS)
The scale contains 14 categories that represent both oral functions (lip, closure, mastication , bolus formation, premature bolus loss, apraxia and oral transit time) and pharyngeal functions (pharyngeal triggering, laryngeal elevation, epiglottic closure, pharyngeal transit time, pharyngeal coating, vallecular and pyriform sinus residues, and tracheal aspiration), with a sum of 100 points.
Korean Mann Assessment of Swallowing Ability (K-MASA)
K-MASA assesses 24 skills related to sensory and oral motor elements of swallowing. Performance for each skill is measured using a 5- or 10-points rating scale and tallied to create a total numeric score out of 200 possible points, which are interpreted as no abnormality (≥178), mild dysphagia (168-177), moderate dysphagia (139-167) and severe (≤138)
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NEUROPHET
Lead sponsor
Bucheon St. Mary's Hospital
Collaborator
Saint Vincent's Hospital, Korea
Collaborator
National Traffic Injury Rehabilitation Hospital
Collaborator
Pusan National University Yangsan Hospital
Collaborator
