Pharyngeal Electrical Stimulation Evaluation for Dysphagia After Stroke

NCT03358810 | Completed DMC

• 1 other identifier: AHE-05
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia Following Cerebral Infarction

Outcome Measures

Primary Outcomes (1)

• 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. 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 Outcomes (1)

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

  11 weeks post final treatment

Study Arms (2)

Active group

ACTIVE COMPARATOR

patients randomized to receive active PES

Device: PES

Sham treatmment

SHAM COMPARATOR

Patients randomized to sham will not receive any PES.

Device: PES

Interventions

PES DEVICE

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.

Also known as: Pharyngeal Electrical Stimulation

Active group; Sham treatmment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Phagenesis Ltd.: lead
• Regulatory and Clinical Research Institute Inc: collaborator
• Cytel Inc.: collaborator

Study Sites (1)

Marianjoy

Wheaton, Illinois, 60187, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 2, 2017
• Study Start: March 31, 2018
• Primary Completion: January 31, 2020
• Study Completion: May 1, 2020
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)