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

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

June 30, 2018

Study Completion Date

September 30, 2018

Conditions
StrokeDysphagia
Interventions
DEVICE

Phagenyx-Catheter, Phagenesis Limited, UK.

Pharyngeal electrical 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 patients. After determining the optimal stimulation intensity, 10 minutes of stimulation are delivered.

DEVICE

Sham stimulation

The intraluminal catheter (Phagenesis Ltd.) for pharyngeal electrical stimulation is placed. In the sham group the optimisation procedure was imitated as closely as possible to mitigate any bias or effect of time spent interacting with the patient during PES, but no current was applied. After this procedure 10 min of sham stimulation were delivered.

Trial Locations (1)

48129

Department of Neurology, University of Muenster, Münster

All Listed Sponsors
lead

University Hospital Muenster

OTHER

NCT02470078 - Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke | Biotech Hunter | Biotech Hunter