Dysphagia Following Cerebral Infarction Clinical Trial
Official title:
Pharyngeal Electrical Stimulation Evaluation for Dysphagia After Stroke
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03441932 -
Evaluation of Morbidity and Mortality Associated With Dysphagia in Stroke Patients Based on Pharyngeal Residue Severity
|
N/A | |
| Completed |
NCT03700853 -
Validation and Reliability Testing of Dysphagia Trained Nurse Assessment
|