Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005509

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to evaluate whether electrical pharyngeal stimulation in
addition to standard care can enhance swallow recovery in tracheostomized dysphagic stroke
patients and thereby facilitate earlier decannulation compared to sham treatment plus
standard care.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005509
  •   2014/01/15
  •   2013/09/24
  •   yes
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Secondary IDs

  •   NCT01956175  (ClinicalTrials.gov)
  •   2011-580  (University Hospital Muenster)
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Health Condition or Problem studied

  •   Stroke
  •   Dysphagia
  •   I63 -  Cerebral infarction
  •   R13 -  Dysphagia
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Interventions/Observational Groups

  •   Device: Electrical pharyngeal stimulation
  •   Device: Sham stimulation
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

- Readiness for decannulation; time frame: 5 days; Difference in readiness for decannulation as assessed by a standardized fiberoptic endoscopic evaluation protocol post-treatment between real and sham treatment groups

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Secondary Outcome

- Pneumonia rate; time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
- Endoscopically assessed swallow function; time frame: 5 days; Improvement of salient endoscopic findings in case decannulation is not possible

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/06/30
  •   40
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

- severe dysphagia due to acute stroke

- completely weaned from mechanical ventilation

- impossibility of decannulation because of severe dysphagia with ongoing aspiration

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Exclusion Criteria

- preexisting dysphagia

- comorbidities that can possibly cause dysphagia

- psychiatric comorbidities

- pacemaker or other implanted electronic devices

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Addresses

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    • University Hospital Muenster
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    • Department of Neurology, University of Muenster
    • Rainer Dziewas, PhD 
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    •   [---]*
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    • Rainer Dziewas, PhD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   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.; 23774336
  •   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.; 12062028
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.