Changes in Sensitivity, Taste and Smell in Stroke Patients

Stroke Clinical Trial

— 5S  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03240965
• Other study ID #: GI-149/16
• Status: Recruiting
• Start date: October 1, 2017
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: University of Giessen
• Contact: Tobias Braun, M.D.
• Phone: +49(0)-641-985
• Email: tobias.braun[@]neuro.med.uni-giessen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dysphagia
• Stroke

Intervention

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
• Neuropsychological testing
Neuropsychological testing for neglect, agnosia

Locations

Country	Name	City	State
Germany	Universitätsklinikum Gießen	Gießen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neuropsychological deficits	Agnosia, neglect	96 hours after initial symptoms
Secondary	Lesion site	Side, vascular territory, swallowing relevant structures	96 hours after initial symptoms
Secondary	Sensitivity	Sensitivity of faucial pillar region	96 hours after initial symptoms
Secondary	Taste/Smell	Smell-/Taste-score	96 hours after initial symptoms