Clinical trial NCT03240965: Changes in Sensitivity, Taste and Smell in Stroke Patients
Official title: Changes in Sensitivity of Swallowing-relevant Structures, Taste and Smell in Stroke Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dysphagia
Stroke
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.

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

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)

Primary outcomes:
measure: Dysphagia
timeFrame: 96 hours after initial symptoms
Secondary outcomes:
measure: Neuropsychological deficits
timeFrame: 96 hours after initial symptoms
measure: Lesion site
timeFrame: 96 hours after initial symptoms
measure: Sensitivity
timeFrame: 96 hours after initial symptoms
measure: Taste/Smell
timeFrame: 96 hours after initial symptoms
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen
state: Hessen
Study officials:
affiliation: University Giessen
name: Tobias Braun, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.