Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01956175
First received: September 24, 2013
Last updated: February 19, 2015
Last verified: February 2015
  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
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: 3 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • modified Rankin Scale (mRS) at discharge [ Time Frame: until discharge ] [ Designated as safety issue: No ]
  • length of stay on ICU / in the hospital and time from stimulation to discharge [ Time Frame: until discharge ] [ Designated as safety issue: No ]

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

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

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:
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: February 19, 2015
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
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Nervous System Diseases
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 03, 2015