Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients

N/ACompletedNCT01956175

University Hospital Muenster30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Stroke Dysphagia

Interventions

Electrical pharyngeal stimulationDEVICE

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.

Sham stimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Neurology, University of Muenster

Münster, Muenster, Germany

Outcomes

Primary Outcomes

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

Time frame: 3 days

Secondary Outcomes

Functional Oral Intake Scale (FOIS) at discharge

Time frame: until discharge

modified Rankin Scale (mRS) at discharge

Time frame: until discharge

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

Time frame: until discharge

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.