Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients

Not Applicable

Completed

• Conditions: Dysphagia; Stroke
• Interventions: Device: Electrical pharyngeal stimulation; Device: Sham stimulation

• Registration Number: NCT01956175
• Lead Sponsor: University Hospital Muenster

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-10-01
• Study First Posted: 2013-10-08
• Primary Completion: 2014-08
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrical pharyngeal stimulation	Electrical pharyngeal stimulation	Electrical pharyngeal stimulation once daily for 10 minutes on three consecutive days.
Sham stimulation	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.

Primary Outcome Measures

Name	Time	Method
Readiness for decannulation	3 days	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

Name	Time	Method
Functional Oral Intake Scale (FOIS) at discharge	until discharge
length of stay on ICU / in the hospital and time from stimulation to discharge	until discharge
modified Rankin Scale (mRS) at discharge	until discharge

Trial Locations

Locations (1)

Department of Neurology, University of Muenster; 🇩🇪 Muenster, Germany