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Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01956175
First Posted: October 8, 2013
Last Update Posted: February 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital Muenster
  Purpose
The purpose of this study is to evaluate whether electrical pharyngeal stimulation in addition to standard care can enhance short-term swallow recovery in tracheostomized dysphagic stroke patients and thereby facilitate earlier decannulation compared to sham treatment plus standard care.

Condition Intervention
Stroke Dysphagia Device: Electrical pharyngeal stimulation Device: Sham stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-centre, Double Blind, Randomised Controlled Clinical Trial to Evaluate the Effect of Electrical Pharyngeal Stimulation as a Treatment for Stroke-related Dysphagia in Tracheostomized Stroke Patients

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Readiness for decannulation [ Time Frame: 3 days ]
    Difference in readiness for decannulation as assessed by a standardized fiberoptic endoscopic evaluation protocol after three days of treatment between real and sham treatment groups


Secondary Outcome Measures:
  • Functional Oral Intake Scale (FOIS) at discharge [ Time Frame: until discharge ]
  • modified Rankin Scale (mRS) at discharge [ Time Frame: until discharge ]
  • length of stay on ICU / in the hospital and time from stimulation to discharge [ Time Frame: until discharge ]

Enrollment: 30
Study Start Date: June 2013
Study Completion Date: December 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electrical pharyngeal stimulation
Electrical pharyngeal stimulation once daily for 10 minutes on three consecutive days.
Device: Electrical pharyngeal stimulation
Electrical pharyngeal stimulation via an intraluminal catheter (Phagenesis Ltd.) once daily for 10 minutes on three consecutive days. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual participants. After determining the optimal stimulation intensity, 10 minutes of stimulation are delivered.
Other Names:
  • Phagenesis Limited, UK.
  • EPS1 device
Sham Comparator: Sham stimulation
Sham stimulation once daily for 10 minutes on three consecutive days. If the subject cannot be decannulated after three days of sham stimulation, another three days of real electrical pharyngeal stimulation will be delivered.
Device: Sham stimulation
The intraluminal catheter (Phagenesis Ltd.) for electrical pharyngeal stimulation is placed. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual participants. After the optimal stimulation intensity has been determined, no electrical stimulation is delivered.

Detailed Description:
Readiness for decannulation is assessed after three days of either real or sham electrical pharyngeal stimulation. In case a patient cannot be decannulated at that time point, there is an open-label follow-up treatment phase, in which every patient in the sham treatment arm gets another three days of real electrical pharyngeal stimulation to not deprive any patient of a potentially beneficial treatment.
  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • severe dysphagia due to acute stroke
  • completely weaned from mechanical ventilation
  • impossibility of decannulation because of severe dysphagia with ongoing aspiration

Exclusion Criteria:

  • preexisting dysphagia
  • comorbidities that can possibly cause dysphagia
  • psychiatric comorbidities
  • pacemaker or other implanted electronic devices
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956175


Locations
Germany
Department of Neurology, University of Muenster
Muenster, Germany, 48129
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Rainer Dziewas, PhD Department of Neurology, University of Muenster
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01956175     History of Changes
Other Study ID Numbers: 2011-580
First Submitted: September 24, 2013
First Posted: October 8, 2013
Last Update Posted: February 20, 2015
Last Verified: February 2015

Keywords provided by University Hospital Muenster:
electrical pharyngeal stimulation
stroke-related dysphagia
tracheostomy
decannulation

Additional relevant MeSH terms:
Stroke
Deglutition Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases