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

Sponsor

University Hospital Muenster (Other)

Overall Status

Completed

CT.gov ID

NCT02470078

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Dysphagia	Device: Phagenyx-Catheter, Phagenesis Limited, UK. Device: Sham stimulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Reintubation rate [120 hours]
Need for reintubation within 120 hours from extubation
Pneumonia rate [120 hours]
Incidence of aspiration pneumonia within 120 hours from extubation

Secondary Outcome Measures

Length of stay [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
Time until oral nutrition [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
PEG tube placement [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
Swallowing function [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurology, University of Muenster	Muenster		Germany	48129

Sponsors and Collaborators

University Hospital Muenster

Investigators

Principal Investigator: Rainer Dziewas, MD, University Hospital Münster

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Muenster

ClinicalTrials.gov Identifier:

NCT02470078

Other Study ID Numbers:

2014-155

First Posted:

Jun 12, 2015

Last Update Posted:

Feb 7, 2020

Last Verified:

Feb 1, 2020

Keywords provided by University Hospital Muenster

extubation

Additional relevant MeSH terms:

Deglutition Disorders

Stroke

Study Results

No Results Posted as of Feb 7, 2020