Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients
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
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Jun 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 24, 2013
CompletedFirst Posted
Study publicly available on registry
October 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 20, 2015
February 1, 2015
1.2 years
September 24, 2013
February 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Readiness for decannulation
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
3 days
Secondary Outcomes (3)
Functional Oral Intake Scale (FOIS) at discharge
until discharge
modified Rankin Scale (mRS) at discharge
until discharge
length of stay on ICU / in the hospital and time from stimulation to discharge
until discharge
Study Arms (2)
Electrical pharyngeal stimulation
EXPERIMENTALElectrical pharyngeal stimulation once daily for 10 minutes on three consecutive days.
Sham stimulation
SHAM COMPARATORSham 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- severe dysphagia due to acute stroke
- completely weaned from mechanical ventilation
- impossibility of decannulation because of severe dysphagia with ongoing aspiration
You may not qualify if:
- preexisting dysphagia
- comorbidities that can possibly cause dysphagia
- psychiatric comorbidities
- pacemaker or other implanted electronic devices
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Neurology, University of Muenster
Münster, Muenster, 48129, Germany
Related Publications (3)
Warnecke T, Suntrup S, Teismann IK, Hamacher C, Oelenberg S, Dziewas R. Standardized endoscopic swallowing evaluation for tracheostomy decannulation in critically ill neurologic patients. Crit Care Med. 2013 Jul;41(7):1728-32. doi: 10.1097/CCM.0b013e31828a4626.
PMID: 23774336BACKGROUNDFraser C, Power M, Hamdy S, Rothwell J, Hobday D, Hollander I, Tyrell P, Hobson A, Williams S, Thompson D. Driving plasticity in human adult motor cortex is associated with improved motor function after brain injury. Neuron. 2002 May 30;34(5):831-40. doi: 10.1016/s0896-6273(02)00705-5.
PMID: 12062028BACKGROUNDSuntrup S, Marian T, Schroder JB, Suttrup I, Muhle P, Oelenberg S, Hamacher C, Minnerup J, Warnecke T, Dziewas R. Electrical pharyngeal stimulation for dysphagia treatment in tracheotomized stroke patients: a randomized controlled trial. Intensive Care Med. 2015 Sep;41(9):1629-37. doi: 10.1007/s00134-015-3897-8. Epub 2015 Jun 13.
PMID: 26077087DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rainer Dziewas, PhD
Department of Neurology, University of Muenster
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2013
First Posted
October 8, 2013
Study Start
June 1, 2013
Primary Completion
August 1, 2014
Study Completion
December 1, 2014
Last Updated
February 20, 2015
Record last verified: 2015-02