Changes in Sensitivity, Taste and Smell in Stroke Patients
NCT ID: NCT03240965
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2017-10-01
2026-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Volunteers <60 years
Volunteers, who are able to consent to participation in the study, as control.
Sensitivity threshold
Determining sensitivity threshold using a pudendal electrode
Taste-/smell-test
Taste-/smell-test
Volunteers >60 years
Volunteers, who are able to consent to participation in the study, as control.
Sensitivity threshold
Determining sensitivity threshold using a pudendal electrode
Taste-/smell-test
Taste-/smell-test
Stroke patients
Stroke patients with supratentorial stroke, who are able to consent to participation in the study.
FEES (flexible endoscopic evaluation of swallowing)
Endoscopical swallowing study in stroke patients only
Sensitivity threshold
Determining sensitivity threshold using a pudendal electrode
Taste-/smell-test
Taste-/smell-test
Neuropsychological testing
Neuropsychological testing for neglect, agnosia
Interventions
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FEES (flexible endoscopic evaluation of swallowing)
Endoscopical swallowing study in stroke patients only
Sensitivity threshold
Determining sensitivity threshold using a pudendal electrode
Taste-/smell-test
Taste-/smell-test
Neuropsychological testing
Neuropsychological testing for neglect, agnosia
Eligibility Criteria
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Inclusion Criteria
* informed consent
Stroke patients:
* informed consent
* new supratentorial stroke (\<72 hours old) confirmed by CT (computed tomography) or MRI (magnetic resonance imaging)
Exclusion Criteria
* 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)
18 Years
ALL
Yes
Sponsors
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University of Giessen
OTHER
Responsible Party
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Tobias Braun
Principal Investigator
Principal Investigators
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Tobias Braun, M.D.
Role: PRINCIPAL_INVESTIGATOR
University Giessen
Locations
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Universitätsklinikum Gießen
Giessen, Hesse, Germany
Countries
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Central Contacts
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Facility Contacts
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Tobias Braun, M.D.
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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GI-149/16
Identifier Type: -
Identifier Source: org_study_id