Pharyngeal Electrical Stimulation Evaluation for Dysphagia After Stroke

Randomization will be stratified at each site in a 1:1 fashion. All patients will have the Phagenyx® Catheter placed prior to randomization, and will receive either an active treatment of Pharyngeal Electrical Stimulation (PES) or a sham treatment performed by a health care professional (HCP) that is un-blinded to treatment assignment. All other speech pathology standard dysphagia care will be provided by a speech language pathologist (SLP) that is blinded to treatment assignment. Administration of all protocol-specific assessments will be conducted by personnel blinded to treatment assignment.

The study will follow an adaptive group sequential design with unblinded sample size re-assessment. To ensure 180 evaluable patients with 7-day data and assuming a 20% dropout rate, 225 patients will be enrolled initially. An interim analysis for futility will occur after the first 60 patients complete their 7-day visits and another interim analysis will be performed for efficacy and futility after 120 patients complete their 7-day visits. The total sample size may be increased up to 338 patients after the second interim analysis to ensure up to 270 evaluable patients. Up to 15 investigational centers across the US and possibly Europe will participate in this study. The enrollment period is expected to be approximately 24 months and patient participation will last for approximately 11 weeks. Patients will be assessed at the following intervals: baseline, 48 hours, 7 days, 14 days or at discharge, whichever is first, and 11 weeks after completion of the study treatments.

Inclusion criteria

• Age ≥ 18 and ≤ 90 years.
• Acute ischemic or hemorrhagic cerebral stroke within 7-28 days of baseline VFSS.
• Score of 0 or 1 on NIHSS question 1a, Level of Consciousness.
• Moderate to severe dysphagia (PAS >4) on baseline VFSS (Baseline VFSS must meet the threshold criteria of demonstrating a PAS of ≥ 4, in three of the six boli (5 mL/1 tsp/bolus), during swallowing "thin liquid" barium media as assessed by the clinical staff administering the VFSS.).
• Willing and able to have the Phagenyx® Catheter placed transnasally.
• Willing and able to provide informed consent.
• Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion criteria

• Brainstem stroke.
• Evidence of traumatic brain injury or subarachnoid hemorrhage.
• Other known brain abnormalities documented by history and/or imaging (e.g., tumor, abnormal white matter, inflammatory neuropathy, myelin delamination, hydrocephalus).
• Dysphagia from conditions other than stroke.
• Pre-stroke history of swallowing complaints or treatment or history of diseases known to be associated with swallowing problems (other neurological, head and neck cancer.
• Distorted oropharyngeal anatomy (e.g., pharyngeal pouch, major pharyngeal surgery or head /neck surgery)
• Currently being treatment for pneumonia.
• Mute, global aphasia; no usable speech or auditory comprehension (scores 3 on NIHSS question 9, Best Language)
• NIHSS score of >25
• Presence of a tracheostomy
• Any active implanted device (e.g., cochlear implant, ICD)
• Any progressive neurological disorder (e.g., Parkinson's Disease, Multiple Sclerosis)
• Cognitive impairment that prevents compliance with protocol-specific instructions and assessments
• Unstable cardiopulmonary condition, i.e., not on maintenance therapy.
• Currently participating in another investigational study
• Pregnant or planning to become pregnant while participating in the clinical study -Known Allergy to oral radiographic contrast media (specifically barium) -