Changes in Sensitivity, Taste and Smell in Stroke Patients

ConditionsDysphagiaStroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Giessen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

informed consent

informed consent

new supratentorial stroke (<72 hours old) confirmed by CT (computed tomography) or MRI (magnetic resonance imaging)

Disqualifiers

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)

Trial 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).

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • FEES (flexible endoscopic evaluation of swallowing)

    Diagnostic test

    Endoscopical swallowing study in stroke patients only

  • Sensitivity threshold

    Other intervention

    Determining sensitivity threshold using a pudendal electrode

  • Taste-/smell-test

    Diagnostic test

    Taste-/smell-test

  • Neuropsychological testing

    Diagnostic test

    Neuropsychological testing for neglect, agnosia

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Volunteers <60 years2 interventions
Group B: Volunteers >60 years2 interventions
Group C: Stroke patients4 interventions

Trial outcomes

Primary outcomes

1

Dysphagia

Changes found in endoscopic swallowing study : Presence and severity of dysphagia (measured with Rosenbek's Penetration/Aspiration-scale)

Time frame
96 hours after initial symptoms

Secondary outcomes

1

Neuropsychological deficits

Agnosia, neglect

Time frame
96 hours after initial symptoms
2

Lesion site

Side, vascular territory, swallowing relevant structures

Time frame
96 hours after initial symptoms
3

Sensitivity

Sensitivity of faucial pillar region

Time frame
96 hours after initial symptoms
4

Taste/Smell

Smell-/Taste-score

Time frame
96 hours after initial symptoms

Other outcomes

Sponsors and contacts

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