NCT03358810

Pharyngeal Electrical Stimulation Evaluation for Dysphagia After Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Phagenesis Ltd. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, sham-controlled, patient masked, outcome assessor-blinded study to assess a Pharyngeal Electrical Stimulation (PES) Catheter for treatment of oropharyngeal dysphagia following a stroke.

Detailed description

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.

Conditions

• Dysphagia Following Cerebral Infarction

Interventions

Type	Name	Description
DEVICE	PES	The PES system is a two-part neurostimulation system. It is composed of a durable component called the Base Station and the single-use sterile disposable Phagenyx® Catheter. The Base Station acts as the user interface and provides the means to generate, optimize and monitor the delivery of electrical stimulation.

Timeline

• Start date: 2018-03-31
• Primary completion: 2020-01-31
• Completion: 2020-05-01
• First posted: 2017-12-02
• Last updated: 2024-12-20

Locations

1 site across 1 country: United States