Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients
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|ClinicalTrials.gov Identifier: NCT01956175|
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : February 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stroke Dysphagia||Device: Electrical pharyngeal stimulation Device: Sham stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Single-centre, Double Blind, Randomised Controlled Clinical Trial to Evaluate the Effect of Electrical Pharyngeal Stimulation as a Treatment for Stroke-related Dysphagia in Tracheostomized Stroke Patients|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Electrical pharyngeal stimulation
Electrical pharyngeal stimulation once daily for 10 minutes on three consecutive days.
Device: Electrical pharyngeal stimulation
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 Comparator: Sham stimulation
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.
Device: Sham stimulation
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.
- Readiness for decannulation [ Time Frame: 3 days ]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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956175
|Department of Neurology, University of Muenster|
|Muenster, Germany, 48129|
|Principal Investigator:||Rainer Dziewas, PhD||Department of Neurology, University of Muenster|