Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients

University Hospital Muenster

Status: Completed

Conditions: Dysphagia; Stroke

Treatments: Device: Sham stimulation; Device: Electrical pharyngeal stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01956175

2011-580

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Electrical pharyngeal stimulation

Experimental group

Description:

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

Treatment:

Device: Electrical pharyngeal stimulation

Sham stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: Sham stimulation