Stroke Clinical Trial
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
Verified date | February 2015 |
Source | University Hospital Muenster |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Department of Neurology, University of Muenster | Muenster |
Lead Sponsor | Collaborator |
---|---|
University Hospital Muenster |
Germany,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Functional Oral Intake Scale (FOIS) at discharge | until discharge | No | |
Secondary | modified Rankin Scale (mRS) at discharge | until discharge | No | |
Secondary | length of stay on ICU / in the hospital and time from stimulation to discharge | until discharge | No |
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