The Effect of Pharyngeal Electrical Stimulation (PES) on Peripheral Biomechanical Aspects of Deglutition
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dysphagia Following Cerebrovascular Accident
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Change in pressure-flow metrics
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The goal of this clinical trial is to clarify which biomechanical aspects of swallowing are altered by Pharyngeal Electrical Stimulation (PES) in stroke patients, ICU patients and healthy volunteers.
The peripheral effect of PES intervention on the biomechanics of swallowing will be evaluated with High Resolution Manometry Impedance (HRMI).
Detailed Description
HRMI combines the evaluation of bolus flow patterns (impedance) and pressure (manometry) generated during swallowing. 20 healthy volunteers will participate, of which 10 will receive PES stimulation and 10 will receive Sham treatment. Maximally 24 patients with dysphagia after acute stroke will be included. Group 1 will receive PES stimulation twice, group 2 will receive PES stimulation and afterwards Sham and group 3 will receive Sham twice. Maximally 40 patients with Critical Illness Polyneuropathy/Myopathy or Post-Extubation Dysphagia will participate, of which 20 will receive PES stimulation and 20 will receive Sham treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in pressure-flow metrics
Time Frame: Change from Baseline at 1-2 hours, 24-72 hours and one week (only in patients) after PES/Sham intervention.
The primary outcome measure are alterations of the biomechanics of swallowing, assessed with HRMI. Analysis of these measurements results in pressure impedance metrics of deglutition, called Pressure Flow Analysis (PFA) parameters. These outcomes are numerical measures that can be compared to reference ranges to detect abnormality and to predict aspiration risk through derivation of a swallow risk index (SRI). An SRI \> 15 indicates global swallowing dysfunction and aspiration risk, so higher scores mean a worse outcome.
Secondary Outcomes
- Functional Oral Intake Scale(Change from Baseline at 24-72 hours and one week after last PES/Sham intervention)
- Brief Esophageal Dysphagia Questionnaire (BEDQ)(Change from Baseline at 24-72 hours and one week after last PES/Sham intervention)
- Change in Dysphagia Severity Rating Scale (DSRS) in patients(Change from Baseline at 24-72 hours and one week after last PES/Sham intervention)
- Change in National Institutes of Health Stroke Scale (NIHSS) in stroke patients(Change from Baseline at 24-72 hours and one week after last PES/Sham intervention)
- Change in Penetration-Aspiration Scale (PAS) in patients(Change from Baseline at 24-72 hours and one week after last PES/Sham intervention)