Dysphagia, Dysphagia Following Cerebrovascular Accident
Conditions
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.
Interventions
A Phagenyx catheter is inserted trans-nasally. The catheter design incorporates a nasogastric feeding tube with built-in stimulation electrodes. The intervention consists of 3 PES sessions. A session is a 10-minute stimulation, once per day. The sessions will be given on three consecutive days at optimal parameters.
OTHERSham treatment
In the Sham condition, the same method and same device will be used. The time spent interacting with the patient will remain constant, including placement of the PES catheter which will be left in situ in the subject for the duration of intervention (10 minutes). However, the base-station will be set to 0 milliampere (mA), so Sham subjects do not receive any active electrical current.
Sponsors
Phagenesis Ltd.
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
volunteers: Healthy volunteers can participate in this study if they: * Are aged between 18 and 80 years old * Have no (history of) chronic disease/medication altering the gastrointestinal (GI) motility * Have no (history of) gastric or gastrointestinal surgery (except appendectomy and cholecystectomy) * Have no (history of) gastrointestinal disease or chronic GI symptoms (heartburn, indigestion/dyspepsia, bloating and constipation) * Have FOIS score 7 or BEDQ score \<10 at baseline * Provide witnessed written informed consent prior to any study procedure And if they do not meet any of the
Exclusion criteria
listed below.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pressure-flow metrics | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional Oral Intake Scale | Change from Baseline at 24-72 hours and one week after last PES/Sham intervention | The Functional Oral Intake Scale (FOIS) encompasses the amount and type of food that can be safely consumed, any special preparations of that food, any maneuvers or compensation being used to facilitate the swallow and the amount of supervision required if any. This valid, reliable, concise scale consists of seven levels that range from a patient who is unable to orally consume any food or liquid at Level 1, to a patient who is consuming an oral diet with no restrictions at Level 7. Higher scores mean a better outcome. |
| Brief Esophageal Dysphagia Questionnaire (BEDQ) | Change from Baseline at 24-72 hours and one week after last PES/Sham intervention | The Brief Esophageal Dysphagia Questionnaire (BEDQ) is a 10-item self-report measure of oesophageal dysphagia symptom frequency (five items), severity (three items), and impaction (two items) with a total score ranging from 0 (asymptomatic) to 40. Higher scores indicate greater severity and frequency of oesophageal dysphagia symptoms, so a worse outcome. |
| Change in Dysphagia Severity Rating Scale (DSRS) in patients | Change from Baseline at 24-72 hours and one week after last PES/Sham intervention | The Dysphagia Severity Rating Scale (DSRS) reflects the feeding status of patients across 3 domains: fluid modification, dietary adaptation and supervision requirements. The total score ranges from 0 (normal fluids, normal diet, and eating independently) to 12 (no oral fluids, no oral feeding). A higher score means a worse outcome. |
| 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 | The National Institutes of Health Stroke Scale (NIHSS) is a reliable, valid 15-item impairment scale for measuring stroke severity. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke: \<5 limited stroke; 5-14 moderately severe stroke; 15-25 severe stroke; \>25 very severe stroke). A higher score means a worse outcome. |
| Change in Penetration-Aspiration Scale (PAS) in patients | Change from Baseline at 24-72 hours and one week after last PES/Sham intervention | The Penetration-Aspiration Scale (PAS) is an 8-point ordinal scale to describe penetration and aspiration events, primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled. Score 1 means that material does not enter the airway (no dysphagia). Score 8 means: material enters the airway, passes below the vocal folds and no effort is made to eject (severe dysphagia). A higher score means a worse outcome. These PAS scores are measured instrumentally by Fibreoptic Endoscopic Evaluation of Swallowing (FEES). |
Countries
Belgium
Contacts
Primary ContactNathalie Rommel
Backup ContactMarthe Everaert
Outcome results
None listed