Pharyngeal Electrical Stimulation Evaluation for Dysphagia After Stroke (NCT03358810) | Clinical Trial Compass
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 range18 Years – 90 Years
SexALL
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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…
What they're measuring
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