CompletedNot Applicable

Pharyngeal Electrical Stimulation Evaluation for Dysphagia After Stroke

United States50 participantsStarted 2018-03-31

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the efficacy of treatment in reducing the severity of unsafe swallows based on PAS(Penetration Aspiration Scale)of each swallow during VFSS

Timeframe: 48 hours post final treatment

Trial details

NCT IDNCT03358810

SponsorPhagenesis Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-01-31

View on ClinicalTrials.gov More Dysphagia Following Cerebral Infarction trials

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.