Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Sham stimulation Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Sham stimulation
    Description: Sham stimulation once daily for 10 minutes on three consecutive days
  • Electrical pharyngeal stimulation Device
    Other Names: Phagenesis Limited, UK.; EPS1 device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Electrical pharyngeal stimulation
    Description: Electrical pharyngeal stimulation once daily for 10 minutes on three consecutive days

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Readiness for decannulation 5 days No
Secondary Pneumonia rate participants will be followed for the duration of hospital stay, an expected average of 3 weeks No
Secondary Endoscopically assessed swallow function 5 days No
Secondary Functional Oral Intake Scale (FOIS) at discharge until discharge No
Secondary modified Rankin Scale (mRS) at discharge until discharge No
Secondary length of stay on ICU / in the hospital and time from stimulation to discharge until discharge No

Sponsors