Pharyngeal Electrical Stimulation Evaluation for Dysphagia After Stroke (PhEED)

December 18, 2024 updated by: Phagenesis Ltd.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Wheaton, Illinois, United States, 60187
        • Marianjoy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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) -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active group
patients randomized to receive active PES
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.
Other Names:
  • Pharyngeal Electrical Stimulation
Sham Comparator: Sham treatmment
Patients randomized to sham will not receive any PES.
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.
Other Names:
  • Pharyngeal Electrical Stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of treatment in reducing the severity of unsafe swallows based on PAS(Penetration Aspiration Scale)of each swallow during VFSS
Time Frame: 48 hours post final treatment

VFSS (Vidoeflouroscopic Swallow Study) Swallowing safety of a bolus of thin and nectar consistency determined by a videofluoroscopic swallowing study.The PAS provides a scoring mechanism for airway closure and clearance during the VFSS. The PAS is a validated 8-point scale that measures penetration and aspiration. Scores are determined primarily by the depth to which material passes into the airway.

  1. Material does not enter airway
  2. Material enters the airway, remains above the vocal folds, and is ejected
  3. Material remains above the vocal folds, and is not ejected from airway
  4. Material contacts the vocal folds, and is ejected
  5. Material contacts the vocal folds, and is not ejected
  6. Material passes below the vocal folds , and is ejected out airway
  7. Material passes below the vocal folds, and is not ejected from trachea
  8. Material enters the airway , and no effort is made to eject it
48 hours post final treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of Phagenyx® treatment in improving nutritional management
Time Frame: 11 weeks post final treatment

Nutritional management changes will be evaluated via:

Time from baseline to removal of enteral feeding (i.e., removal of NG tube or PEG or transition to oral feeding, or first diet upgrade,Functional Oral Intake Scale (FOIS) at 7 days, 14 days or discharge, whichever is first, and 11 weeks
11 weeks post final treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Phagenesis Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regulatory and Clinical Research Institute Inc
Cytel Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AHE-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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