Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke

University Hospital Muenster

Status: Completed

Conditions: Dysphagia; Stroke

Treatments: Device: Sham stimulation; Device: Phagenyx-Catheter, Phagenesis Limited, UK.

Study type: Interventional

Funder types: Other

Identifiers

NCT02470078

2014-155

Details and patient eligibility

About

The purpose of this study is to evaluate whether pharyngeal electrical stimulation in addition to standard care can enhance swallowing recovery in severely dysphagic stroke patients post extubation compared to sham treatment plus standard care.

Enrollment: 60 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• severe dysphagia post extubation due to acute stroke

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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60 participants in 2 patient groups

Pharyngeal electrical stimulation

Experimental group

Description:

Pharyngeal electrical stimulation once daily for 10 minutes on three consecutive days.

Treatment:

Device: Phagenyx-Catheter, Phagenesis Limited, UK.

Sham stimulation

Sham Comparator group

Description:

Sham stimulation once daily for 10 minutes on three consecutive days.

Treatment:

Device: Sham stimulation