Skip to main content
Clinical Trials/NCT03240965
NCT03240965
Recruiting
Not Applicable

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

University of Giessen1 site in 1 country200 target enrollmentOctober 1, 2017
ConditionsDysphagiaStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dysphagia
Sponsor
University of Giessen
Enrollment
200
Locations
1
Primary Endpoint
Dysphagia
Status
Recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
December 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tobias Braun

Principal Investigator

University of Giessen

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

  • Neuropsychological deficits(96 hours after initial symptoms)
  • Lesion site(96 hours after initial symptoms)
  • Taste/Smell(96 hours after initial symptoms)
  • Sensitivity(96 hours after initial symptoms)

Study Sites (1)

Loading locations...

Similar Trials