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Changes in Sensitivity, Taste and Smell in Stroke Patients

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03240965
Acronym
5S
Enrollment
200
Registered
2017-08-07
Start date
2017-10-01
Completion date
2026-12-31
Last updated
2023-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Stroke

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

Interventions

DIAGNOSTIC_TESTFEES (flexible endoscopic evaluation of swallowing)

Endoscopical swallowing study in stroke patients only

OTHERSensitivity threshold

Determining sensitivity threshold using a pudendal electrode

DIAGNOSTIC_TESTTaste-/smell-test

Taste-/smell-test

DIAGNOSTIC_TESTNeuropsychological testing

Neuropsychological testing for neglect, agnosia

Sponsors

University of Giessen
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Dysphagia96 hours after initial symptomsChanges found in endoscopic swallowing study : Presence and severity of dysphagia (measured with Rosenbek's Penetration/Aspiration-scale)

Secondary

MeasureTime frameDescription
Neuropsychological deficits96 hours after initial symptomsAgnosia, neglect
Lesion site96 hours after initial symptomsSide, vascular territory, swallowing relevant structures
Sensitivity96 hours after initial symptomsSensitivity of faucial pillar region
Taste/Smell96 hours after initial symptomsSmell-/Taste-score

Countries

Germany

Contacts

Primary ContactTobias Braun, M.D.
tobias.braun@neuro.med.uni-giessen.de+49(0)-641-985

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026