Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke

February 5, 2020 updated by: University Hospital Muenster

Randomised Controlled Trial of Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke Patients

The purpose of this study is to evaluate whether pharyngeal electrical stimulation in addition to standard care can enhance swallowing recovery in severely dysphagic stroke patients post extubation compared to sham treatment plus standard care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Muenster, Germany, 48129
        • Department of Neurology, University of Muenster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- severe dysphagia post extubation due to acute stroke

Exclusion Criteria:

  • preexisting dysphagia
  • comorbidities that can possibly cause dysphagia
  • psychiatric comorbidities
  • pacemaker or other implanted electronic devices

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharyngeal electrical stimulation
Pharyngeal electrical stimulation once daily for 10 minutes on three consecutive days.
Device: Phagenyx-Catheter, Phagenesis Limited, UK.
Pharyngeal electrical 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 patients. After determining the optimal stimulation intensity, 10 minutes of stimulation are delivered.
Sham Comparator: Sham stimulation
Sham stimulation once daily for 10 minutes on three consecutive days.
Device: Sham stimulation
The intraluminal catheter (Phagenesis Ltd.) for pharyngeal electrical stimulation is placed. In the sham group the optimisation procedure was imitated as closely as possible to mitigate any bias or effect of time spent interacting with the patient during PES, but no current was applied. After this procedure 10 min of sham stimulation were delivered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reintubation rate
Time Frame: 120 hours
Need for reintubation within 120 hours from extubation
120 hours
Pneumonia rate
Time Frame: 120 hours
Incidence of aspiration pneumonia within 120 hours from extubation
120 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: Participants will be followed for the duration of stay on the intensive care unit, an expected average of 3 weeks
Length of stay on the intensive care unit
Participants will be followed for the duration of stay on the intensive care unit, an expected average of 3 weeks
Time until oral nutrition
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Time span from extubation until consumption of an completely oral diet is safely possible
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
PEG tube placement
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks.
Number of participants needing percutaneous endogastric tube placement due to persistent severe dysphagia
Participants will be followed for the duration of hospital stay, an expected average of 5 weeks.
Swallowing function
Time Frame: after 3 days of treatment
Salient semiquantitative parameters of swallowing function (leaking, penetration, aspiration, residues, delayed triggering of swallow reflex) as assessed by a standardized fiberoptic endoscopic evaluation protocol after three days of treatment
after 3 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Investigators

  • Principal Investigator: Rainer Dziewas, MD, University Hospital Münster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-155

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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