Changes in Sensitivity, Taste and Smell in Stroke Patients

NCT03240965 | Recruiting

• 1 other identifier: GI-149/16
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia; Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Neuropsychological deficits

  96 hours after initial symptoms

• Lesion site

  96 hours after initial symptoms

• Sensitivity

  96 hours after initial symptoms

• Taste/Smell

  96 hours after initial symptoms

Study Arms (3)

Volunteers <60 years

Volunteers, who are able to consent to participation in the study, as control.

Other: Sensitivity threshold; Diagnostic Test: Taste-/smell-test

Volunteers >60 years

Volunteers, who are able to consent to participation in the study, as control.

Other: Sensitivity threshold; Diagnostic Test: Taste-/smell-test

Stroke patients

Stroke patients with supratentorial stroke, who are able to consent to participation in the study.

Diagnostic Test: FEES (flexible endoscopic evaluation of swallowing); Other: Sensitivity threshold; Diagnostic Test: Taste-/smell-test; Diagnostic Test: Neuropsychological testing

Interventions

FEES (flexible endoscopic evaluation of swallowing) DIAGNOSTIC_TEST

Endoscopical swallowing study in stroke patients only

Stroke patients

Sensitivity threshold OTHER

Determining sensitivity threshold using a pudendal electrode

Stroke patients; Volunteers <60 years; Volunteers >60 years

Taste-/smell-test DIAGNOSTIC_TEST

Taste-/smell-test

Stroke patients; Volunteers <60 years; Volunteers >60 years

Neuropsychological testing DIAGNOSTIC_TEST

Neuropsychological testing for neglect, agnosia

Stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Volunteers:
• informed consent
• Stroke patients:
• informed consent
• new supratentorial stroke (\<72 hours old) confirmed by CT (computed tomography) or MRI (magnetic resonance imaging)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

Universitätsklinikum Gießen

Giessen, Hesse, 35392, Germany

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tobias Braun, M.D.

  University Giessen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Braun, M.D.

CONTACT

+49(0)-641-985; tobias.braun@neuro.med.uni-giessen.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 7, 2017
• Study Start: October 1, 2017
• Primary Completion: February 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

DE (1)