Clinical trial NCT01956175: Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Dysphagia
Keywords: electrical pharyngeal stimulation
stroke-related dysphagia
tracheostomy
decannulation
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Readiness for decannulation
timeFrame: 3 days
Secondary outcomes:
measure: Functional Oral Intake Scale (FOIS) at discharge
timeFrame: until discharge
measure: modified Rankin Scale (mRS) at discharge
timeFrame: until discharge
measure: length of stay on ICU / in the hospital and time from stimulation to discharge
timeFrame: until discharge
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Neurology, University of Muenster
Study officials:
affiliation: Department of Neurology, University of Muenster
name: Rainer Dziewas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fraser 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.
citation: Suntrup 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.