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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01956175
Other study ID # 2011-580
Secondary ID
Status Completed
Phase N/A
First received September 24, 2013
Last updated February 19, 2015
Start date June 2013
Est. completion date December 2014

Study information

Verified date February 2015
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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 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.

Locations

Country Name City State
Germany Department of Neurology, University of Muenster Muenster

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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

Outcome

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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