Status:
COMPLETED
Pharyngeal Electrical Stimulation Evaluation for Dysphagia After Stroke
Lead Sponsor:
Phagenesis Ltd.
Collaborating Sponsors:
Regulatory and Clinical Research Institute Inc
Cytel Inc.
Conditions:
Dysphagia Following Cerebral Infarction
Eligibility:
All Genders
18-90 years
Phase:
NA
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 ...
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 E...
Eligibility Criteria
Inclusion
- 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
- 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) -
Key Trial Info
Start Date :
March 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03358810
Start Date
March 31 2018
End Date
May 1 2020
Last Update
December 20 2024
Active Locations (1)
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1
Marianjoy
Wheaton, Illinois, United States, 60187