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| Name | Class |
|---|---|
| Phagenesis Ltd. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PES stimulation in volunteers | Experimental | 10 volunteers will receive PES stimulation. For healthy volunteers, the study protocol includes 1 stimulation trial. Each stimulation trial 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, as reported by Fraser et al. (2003). |
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| Sham treatment in volunteers | Sham Comparator | 10 volunteers will receive Sham 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. |
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| PES stimulation + PES stimulation in stroke patients | Experimental | Max 8 patients will receive PES stimulation twice. For patients, the protocol thus includes 2 stimulation trails. Each stimulation trial consists of 3 PES sessions, so they receive 6 PES sessions in total. A session is a 10-minute stimulation, once per day. The sessions will be given on three consecutive days at optimal parameters, as reported by Fraser et al. (2003). |
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| PES stimulation + Sham treatment in stroke patients | Other | Max 8 patients will receive PES stimulation and afterwards Sham treatment. During the first stimulation trial, they will receive 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, as reported by Fraser et al. (2003). During the second stimulation trial, the same method and same device will be used. However, the base-station will be set to 0 milliampere (mA), so Sham subjects do not receive any active electrical current. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharyngeal Electrical Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pressure-flow metrics | 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. | Change from Baseline at 1-2 hours, 24-72 hours and one week (only in patients) after PES/Sham intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Oral Intake Scale | 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. |
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Inclusion Criteria volunteers:
Healthy volunteers can participate in this study if they:
Exclusion Criteria volunteers:
Healthy volunteers will be excluded if they:
Inclusion Criteria patients:
Dysphagic patients are eligible for study participation if they:
Are admitted to the hospital because of acute stroke (acute means assessment within one month post stroke onset)
Are aged between 18 and 85 years old
Are medically stable, alert or arousable (Stroke: National Institutes of Health Stroke Scale (NIHSS) 0/1, ICU: Richmond Agitation-Sedation Scale (RASS) -1/0/+1 and Intensive Care Delirium Screening Checklist (ICDSC) <4)
Have clinical (oropharyngeal) dysphagia well identified using the FOIS/DSRS/ BEDQ/PAS at baseline. In line with earlier studies(16,27), we use the following criteria: a DSRS score of 6 or higher; or a FOIS-score equal to or lower than 5; or a BEDQ score of 10 or higher or (when no oral food intake is possible and DSRS score is 12/FOIS score is 1) a PAS-score of 4 or higher
Give (or have a witness to give) voluntary written informed consent And if they do not meet any of the exclusion criteria listed hereunder.
Exclusion Criteria patients:
Patients will be excluded from study participation if:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie Rommel | Contact | +3216330483 | nathalie.rommel@kuleuven.be | |
| Marthe Everaert | Contact | +3216320429 | marthe.everaert@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Nathalie Rommel | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | Vlaam-Brabant | 3000 | Belgium |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Sham treatment + Sham treatment in stroke patients | Sham Comparator | Max 8 patients will receive Sham twice. 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. |
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| PES stimulation + PES stimulation in ICU patients | Experimental | Max 20 patients will receive PES stimulation twice. For patients, the protocol thus includes 2 stimulation trails. Each stimulation trial consists of 3 PES sessions, so they receive 6 PES sessions in total. A session is a 10-minute stimulation, once per day. The sessions will be given on three consecutive days at optimal parameters, as reported by Fraser et al. (2003). |
|
| Sham treatment + Sham treatment in ICU patients | Experimental | Max 20 patients will receive Sham twice. 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. |
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| Sham treatment | Other | 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. |
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| Change from Baseline at 24-72 hours and one week after last PES/Sham intervention |
| Brief Esophageal Dysphagia Questionnaire (BEDQ) | 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 from Baseline at 24-72 hours and one week after last PES/Sham intervention |
| Change in Dysphagia Severity Rating Scale (DSRS) in patients | 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 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 | 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 from Baseline at 24-72 hours and one week after last PES/Sham intervention |
| Change in Penetration-Aspiration Scale (PAS) in patients | 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). | Change from Baseline at 24-72 hours and one week after last PES/Sham intervention |
| D010038 | Otorhinolaryngologic Diseases |