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Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients

Primary Purpose

Stroke, Dysphagia

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Electrical pharyngeal stimulation

Sham stimulation

About this trial

This is an interventional treatment trial for Stroke focused on measuring electrical pharyngeal stimulation, stroke-related dysphagia, tracheostomy, decannulation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Neurology, University of Muenster

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Electrical pharyngeal stimulation

Sham stimulation

Arm Description

Electrical pharyngeal stimulation once daily for 10 minutes on three consecutive days.

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.

Outcomes

Primary Outcome Measures

Readiness for decannulation

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

modified Rankin Scale (mRS) at discharge

length of stay on ICU / in the hospital and time from stimulation to discharge

Full Information

NCT ID

NCT01956175

First Posted

September 24, 2013

Last Updated

February 19, 2015

Sponsor

University Hospital Muenster

1. Study Identification

Unique Protocol Identification Number

NCT01956175

Brief Title

Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Muenster

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Dysphagia

Keywords

electrical pharyngeal stimulation, stroke-related dysphagia, tracheostomy, decannulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Electrical pharyngeal stimulation

Arm Type

Experimental

Arm Description

Electrical pharyngeal stimulation once daily for 10 minutes on three consecutive days.

Arm Title

Sham stimulation

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Electrical pharyngeal stimulation

Other Intervention Name(s)

Phagenesis Limited, UK., EPS1 device

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Readiness for decannulation

Description

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

Time Frame

3 days

Secondary Outcome Measure Information:

Title

Functional Oral Intake Scale (FOIS) at discharge

Time Frame

until discharge

Title

modified Rankin Scale (mRS) at discharge

Time Frame

until discharge

Title

length of stay on ICU / in the hospital and time from stimulation to discharge

Time Frame

until discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rainer Dziewas, PhD

Organizational Affiliation

Department of Neurology, University of Muenster

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Neurology, University of Muenster

City

Muenster

ZIP/Postal Code

48129

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

23774336

Citation

Warnecke T, Suntrup S, Teismann IK, Hamacher C, Oelenberg S, Dziewas R. Standardized endoscopic swallowing evaluation for tracheostomy decannulation in critically ill neurologic patients. Crit Care Med. 2013 Jul;41(7):1728-32. doi: 10.1097/CCM.0b013e31828a4626.

Results Reference

background

PubMed Identifier

12062028

Citation

Fraser C, Power M, Hamdy S, Rothwell J, Hobday D, Hollander I, Tyrell P, Hobson A, Williams S, Thompson D. Driving plasticity in human adult motor cortex is associated with improved motor function after brain injury. Neuron. 2002 May 30;34(5):831-40. doi: 10.1016/s0896-6273(02)00705-5.

Results Reference

background

PubMed Identifier

26077087

Citation

Suntrup S, Marian T, Schroder JB, Suttrup I, Muhle P, Oelenberg S, Hamacher C, Minnerup J, Warnecke T, Dziewas R. Electrical pharyngeal stimulation for dysphagia treatment in tracheotomized stroke patients: a randomized controlled trial. Intensive Care Med. 2015 Sep;41(9):1629-37. doi: 10.1007/s00134-015-3897-8. Epub 2015 Jun 13.

Results Reference

derived

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Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients

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