Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
Other Names:
|
| 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.
|
Outcome Measures
Primary Outcome Measures
- Readiness for decannulation [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
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Neurology, University of Muenster | Muenster | Germany | 48129 |
Sponsors and Collaborators
- University Hospital Muenster
Investigators
- Principal Investigator: Rainer Dziewas, PhD, Department of Neurology, University of Muenster
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 2011-580