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Recruiting NCT03240965

Changes in Sensitivity, Taste and Smell in Stroke Patients

— Observational Dysphagia Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FEES (flexible endoscopic evaluation of swallowing), Sensitivity threshold, Taste-/smell-test, Neuropsychological testing.
Who it may be relevant to
Registry conditions: Dysphagia, Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Changes in Sensitivity of Swallowing-relevant Structures, Taste and Smell in Stroke Patients

Overview

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.

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

Interventions

  • 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

  • Dysphagia [Time frame: 96 hours after initial symptoms]
Secondary outcome measures (4)
  • Neuropsychological deficits [Time frame: 96 hours after initial symptoms]
  • Lesion site [Time frame: 96 hours after initial symptoms]
  • Sensitivity [Time frame: 96 hours after initial symptoms]
  • Taste/Smell [Time frame: 96 hours after initial symptoms]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

Germany · 1 center
  • Universitätsklinikum Gießen — Giessen

Publications

  • Ali GN, Laundl TM, Wallace KL, Shaw DW, Decarle DJ, Cook IJ. Influence of mucosal receptors on deglutitive regulation of pharyngeal and upper esophageal sphincter function. Am J Physiol. 1994 Oct;267(4 Pt 1):G644-9. doi: 10.1152/ajpgi.1994.267.4.G644. PMID 7943330
  • Kidd D, Lawson J, Nesbitt R, MacMahon J. Aspiration in acute stroke: a clinical study with videofluoroscopy. Q J Med. 1993 Dec;86(12):825-9. PMID 8108539
  • Power ML, Hamdy S, Singh S, Tyrrell PJ, Turnbull I, Thompson DG. Deglutitive laryngeal closure in stroke patients. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):141-6. doi: 10.1136/jnnp.2006.101857. Epub 2006 Sep 29. PMID 17012336
  • Braun T, Doerr JM, Peters L, Viard M, Reuter I, Prosiegel M, Weber S, Yeniguen M, Tschernatsch M, Gerriets T, Juenemann M, Huttner HB, Hamzic S. Age-related changes in oral sensitivity, taste and smell. Sci Rep. 2022 Jan 27;12(1):1533. doi: 10.1038/s41598-022-05201-2. PMID 35087097
  • Braun T, Hamzic S, Doerr JM, Peters L, Viard M, Reuter I, Prosiegel M, Weber S, Yenigun M, Tschernatsch M, Gerriets T, Juenemann M. Facilitation of oral sensitivity by electrical stimulation of the faucial pillars. Sci Rep. 2021 May 24;11(1):10762. doi: 10.1038/s41598-021-90262-y. PMID 34031508

Identifiers

NCT: NCT03240965 · GI-149/16

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗