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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Dysphagia
• Intervention / Treatment: Other: Sensitivity threshold; Diagnostic test: Taste-/smell-test; Diagnostic test: FEES (flexible endoscopic evaluation of swallowing); 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

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Tobias Braun, M.D.; Phone Number: 56827 +49(0)-641-985; Email: tobias.braun@neuro.med.uni-giessen.de

Study Locations

• Germany
  • Hessen
    • Gießen, Hessen, Germany, 35392
      • Recruiting
      • Universitätsklinikum Gießen
      • Contact: Tobias Braun, M.D.; Phone Number: 56827 +49 641 985; Email: tobias.braun@neuro.med.uni-giessen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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).

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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.	Other: Sensitivity threshold; Determining sensitivity threshold using a pudendal electrode; Diagnostic test: Taste-/smell-test; Taste-/smell-test; Diagnostic test: FEES (flexible endoscopic evaluation of swallowing); Endoscopical swallowing study in stroke patients only; Diagnostic test: Neuropsychological testing; Neuropsychological testing for neglect, agnosia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysphagia	Changes found in endoscopic swallowing study : Presence and severity of dysphagia (measured with Rosenbek's Penetration/Aspiration-scale)	96 hours after initial symptoms

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropsychological deficits	Agnosia, neglect	96 hours after initial symptoms
Lesion site	Side, vascular territory, swallowing relevant structures	96 hours after initial symptoms
Sensitivity	Sensitivity of faucial pillar region	96 hours after initial symptoms
Taste/Smell	Smell-/Taste-score	96 hours after initial symptoms

Collaborators and Investigators

• Sponsor: University of Giessen
• Investigators: Principal Investigator: Tobias Braun, M.D., University Giessen

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: GI-149/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No