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Changes in Sensitivity, Taste and Smell in Stroke Patients (5S)

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ClinicalTrials.gov Identifier: NCT03240965
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Tobias Braun, University of Giessen

Brief Summary:
This study evaluates changes in swallowing using endoscopic swallowing studies and measuring of pharyngeal sensitivity, taste and smell in stroke patients. Younger (<60 years) and older (>60 years) volunteers will serve as control.

Condition or disease Intervention/treatment
Dysphagia Stroke Diagnostic Test: FEES (flexible endoscopic evaluation of swallowing) Other: Sensitivity threshold Diagnostic Test: Taste-/smell-test Diagnostic Test: Neuropsychological testing

Detailed Description:

Stroke is the second leading cause of death. At least 50% of stroke patients develop dysphagia, leading to aspiration pneumonia, which is the main cause of death in stroke [2].

It is assumed that normal sensitivity is vital for aspiration-free swallowing and for the triggering of the swallowing reflex.

Ali et al. demonstrated aspiration-free swallowing in healthy volunteers who underwent local anaesthesia of oral and pharyngeal structures [1]. Power et al. showed a reduced sensitivity of pharyngeal structures in stroke patients prone to aspiration [3].

By combining measuring sensitivity and flexible endoscopic swallowing studies, this study further investigates the role of sensitivity in swallowing Neuropsychological deficits of swallowing, such as swallowing apraxia or buccal hemineglect, is assessed by neuropsychological testing.

Additionally, there is no systematic research investigating the change in smell and taste in correlation with changes in stroke patients


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Changes in Sensitivity of Swallowing-relevant Structures, Taste and Smell in Stroke Patients
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Volunteers <60 years
Volunteers, who are able to consent to participation in the study, as control.
Other: Sensitivity threshold
Determining sensitivity threshold using a pudendal electrode

Diagnostic Test: Taste-/smell-test
Taste-/smell-test

Volunteers >60 years
Volunteers, who are able to consent to participation in the study, as control.
Other: Sensitivity threshold
Determining sensitivity threshold using a pudendal electrode

Diagnostic Test: Taste-/smell-test
Taste-/smell-test

Stroke patients
Stroke patients with supratentorial stroke, who are able to consent to participation in the study.
Diagnostic Test: FEES (flexible endoscopic evaluation of swallowing)
Endoscopical swallowing study in stroke patients only

Other: Sensitivity threshold
Determining sensitivity threshold using a pudendal electrode

Diagnostic Test: Taste-/smell-test
Taste-/smell-test

Diagnostic Test: Neuropsychological testing
Neuropsychological testing for neglect, agnosia




Primary Outcome Measures :
  1. Dysphagia [ Time Frame: 96 hours after initial symptoms ]

    Changes found in endoscopic swallowing study :

    Presence and severity of dysphagia (measured with Rosenbek's Penetration/Aspiration-scale)



Secondary Outcome Measures :
  1. Neuropsychological deficits [ Time Frame: 96 hours after initial symptoms ]
    Agnosia, neglect

  2. Lesion site [ Time Frame: 96 hours after initial symptoms ]
    Side, vascular territory, swallowing relevant structures

  3. Sensitivity [ Time Frame: 96 hours after initial symptoms ]
    Sensitivity of faucial pillar region

  4. Taste/Smell [ Time Frame: 96 hours after initial symptoms ]
    Smell-/Taste-score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Stroke patients are recruited in a university hospital's department of neurology.

Volunteers >60years are recruited in a trauma surgery ward at the same university hospital.

Volunteers <60 are recruited without specified characteristics (aside from in-/exclusion criteria).

Criteria

Inclusion Criteria:

Volunteers:

  • informed consent

Stroke patients:

  • informed consent
  • new supratentorial stroke (<72 hours old) confirmed by CT (computed tomography) or MRI (magnetic resonance imaging)

Exclusion Criteria:

  • pre-existing stroke oder dysphagia
  • extensive white matter lesions in CT- or MRI-scan
  • allergies to odorous substances or flavoring
  • contraindications for FEES (flexible endoscopic evaluation of swallowing), CT or MRI (stroke patients only)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240965


Contacts
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Contact: Tobias Braun, M.D. +49(0)-641-985 ext 56827 tobias.braun@neuro.med.uni-giessen.de

Locations
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Germany
Universitätsklinikum Gießen Recruiting
Gießen, Hessen, Germany, 35392
Contact: Tobias Braun, M.D.    +49 641 985 ext 56827    tobias.braun@neuro.med.uni-giessen.de   
Sponsors and Collaborators
University of Giessen
Investigators
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Principal Investigator: Tobias Braun, M.D. University Giessen

Publications:
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Responsible Party: Tobias Braun, Principal Investigator, University of Giessen
ClinicalTrials.gov Identifier: NCT03240965     History of Changes
Other Study ID Numbers: GI-149/16
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases