Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospital Muenster
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01956175
First received: September 24, 2013
Last updated: October 1, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to evaluate whether electrical pharyngeal stimulation in addition to standard care can enhance 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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: 5 days ] [ Designated as safety issue: No ]
    Difference in readiness for decannulation as assessed by a standardized fiberoptic endoscopic evaluation protocol post-treatment between real and sham treatment groups


Secondary Outcome Measures:
  • Pneumonia rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]
  • Endoscopically assessed swallow function [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Improvement of salient endoscopic findings in case decannulation is not possible


Estimated Enrollment: 40
Study Start Date: June 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01956175

Contacts
Contact: Rainer Dziewas, PhD +4925183 48172 dziewas@uni-muenster.de

Locations
Germany
Department of Neurology, University of Muenster Recruiting
Muenster, Germany, 48129
Contact: Rainer Dziewas, PhD    +4925183 ext 48172    dziewas@uni-muenster.de   
Principal Investigator: Rainer Dziewas, PhD         
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Rainer Dziewas, PhD Department of Neurology, University of Muenster
  More Information

Publications:
Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01956175     History of Changes
Other Study ID Numbers: 2011-580
Study First Received: September 24, 2013
Last Updated: October 1, 2013
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on August 21, 2014