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NCT Number: NCT03240965

Changes in Sensitivity, 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Gießen

Giessen, Hesse, 35392, Germany

Location status: Recruiting

Location contact

Tobias Braun, M.D.

CONTACT

[email protected]

+49 641 985 ext. 56827

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FEES (flexible endoscopic evaluation of swallowing)

Diagnostic Test

Endoscopical swallowing study in stroke patients only

Sensitivity threshold

Other

Determining sensitivity threshold using a pudendal electrode

Taste-/smell-test

Diagnostic Test

Taste-/smell-test

Neuropsychological testing

Diagnostic Test

Neuropsychological testing for neglect, agnosia

Primary outcomes

  1. Dysphagia

    Time frame: 96 hours after initial symptoms

    Changes found in endoscopic swallowing study :

    Presence and severity of dysphagia (measured with Rosenbek's Penetration/Aspiration-scale)

Secondary outcomes

  1. Neuropsychological deficits

    Time frame: 96 hours after initial symptoms

    Agnosia, neglect

  2. Lesion site

    Time frame: 96 hours after initial symptoms

    Side, vascular territory, swallowing relevant structures

  3. Sensitivity

    Time frame: 96 hours after initial symptoms

    Sensitivity of faucial pillar region

  4. Taste/Smell

    Time frame: 96 hours after initial symptoms

    Smell-/Taste-score

Study contacts

Contact information is provided by the study sponsor or research team.

Tobias Braun, M.D.

CONTACT

[email protected]

+49(0)-641-985 ext. 56827

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

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

Acronym: 5S

Important dates

Study start
2017
Primary completion
2025
Study completion
2026
First posted
Aug 7, 2017
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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