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Pharyngeal Electrical Stimulation Evaluation for Dysphagia After Stroke (PhEED)

Primary Purpose

Dysphagia Following Cerebral Infarction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PES

About this trial

This is an interventional treatment trial for Dysphagia Following Cerebral Infarction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) -

Sites / Locations

Marianjoy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active group

Sham treatmment

Arm Description

patients randomized to receive active PES

Patients randomized to sham will not receive any PES.

Outcomes

Primary Outcome Measures

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

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. Material does not enter airway Material enters the airway, remains above the vocal folds, and is ejected Material remains above the vocal folds, and is not ejected from airway Material contacts the vocal folds, and is ejected Material contacts the vocal folds, and is not ejected Material passes below the vocal folds , and is ejected out airway Material passes below the vocal folds, and is not ejected from trachea Material enters the airway , and no effort is made to eject it

Secondary Outcome Measures

To evaluate the efficacy of Phagenyx® treatment in improving nutritional management

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

Full Information

NCT ID

NCT03358810

First Posted

November 21, 2017

Last Updated

July 28, 2020

Sponsor

Phagenesis Ltd.

Collaborators

Regulatory and Clinical Research Institute Inc, Cytel Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03358810

Brief Title

Pharyngeal Electrical Stimulation Evaluation for Dysphagia After Stroke

Acronym

PhEED

Official Title

Pharyngeal Electrical Stimulation Evaluation for Dysphagia After Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

March 31, 2018 (Actual)

Primary Completion Date

January 31, 2020 (Actual)

Study Completion Date

May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Phagenesis Ltd.

Collaborators

Regulatory and Clinical Research Institute Inc, Cytel Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysphagia Following Cerebral Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active group

Arm Type

Active Comparator

Arm Description

patients randomized to receive active PES

Arm Title

Sham treatmment

Arm Type

Sham Comparator

Arm Description

Patients randomized to sham will not receive any PES.

Intervention Type

Device

Intervention Name(s)

PES

Other Intervention Name(s)

Pharyngeal Electrical Stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

48 hours post final treatment

Secondary Outcome Measure Information:

Title

To evaluate the efficacy of Phagenyx® treatment in improving nutritional management

Description

Time Frame

11 weeks post final treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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) -

Facility Information:

Facility Name

Marianjoy

City

Wheaton

State/Province

Illinois

ZIP/Postal Code

60187

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Pharyngeal Electrical Stimulation Evaluation for Dysphagia After Stroke

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