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The Effect of Pharyngeal Electrical Stimulation on Peripheral Biomechanical Aspects of Deglutition (PES)

Primary Purpose

Dysphagia Following Cerebrovascular Accident, Dysphagia

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Pharyngeal Electrical Stimulation
Sham treatment
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia Following Cerebrovascular Accident

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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. Exclusion Criteria volunteers: Healthy volunteers will be excluded if they: Are aged <18 years or >80 years Have (any history of) a chronic disease/medication altering the GI motility Have (any history of) gastric or gastrointestinal surgery (except appendectomy and cholecystectomy) Have (any history of) gastrointestinal disease or chronic GI symptoms (heartburn, indigestion/dyspepsia, bloating and constipation) Have a FOIS score <7 or a BEDQ score ≥ 10 at baseline Fail to provide witnessed written informed consent prior to any study procedure Inclusion Criteria patients: Dysphagic stroke patients are eligible for study participation if they: Are admitted to the hospital because of first ever acute stroke (acute means assessment within one month post stroke onset) Hemorrhagic and ischemic stroke Supratentorial and infratentorial stroke Are aged between 18 and 80 years old Are medically stable, alert or arousable Have clinical (oropharyngeal) dysphagia well identified using the FOIS/DSRS/ BEDQ/PAS at baseline. In line with earlier studies, 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 below. Exclusion Criteria patients: Patients will be excluded from study participation if: They are aged <18 years or >80 years They have an additional condition (e.g. advanced dementia) or diagnosis of a progressive neurological disorder or neuromuscular disorder that may explain dysphagia They have normal swallowing at baseline assessed with FOIS/DSRS/BEDQ/PAS They participate in any other study potentially influencing the outcome of PES, both medicinal or medical device product related and for which the patient signed a consent form for his/her study participation They receive or have received within one month prior to the intended PES treatment any form of non-invasive brain stimulation or percutaneous electrical stimulation therapy to treat dysphagia. (This is no issue, since this type of treatment is not performed at University Hospitals Leuven (UZ Leuven). It is not possible to pass a standard nasogastric tube, for example, nasal, oral or pharyngeal anatomical abnormalities that preclude passage of a feeding tube, oral intubation, history of oesophageal perforation, stricture or pouch They have a cardiac or respiratory condition that might render the insertion of a catheter into the throat unsafe (Atrial fibrillation does not render the insertion of a catheter unsafe) They have a permanently implanted electrical device They are pregnant They present with an oropharyngeal infection. This should be treated and resolved before the PES catheter is inserted They require a magnetic resonance imaging (MRI) scan during PES treatment. Insertion of the PES catheter should either be delayed until such time as the MRI has been completed, or the PES catheter should be removed and discarded and a new catheter inserted after the MRI is completed

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Sham Comparator

Experimental

Other

Sham Comparator

Arm Label

PES stimulation in volunteers

Sham treatment in volunteers

PES stimulation + PES stimulation in patients

PES stimulation + Sham treatment in patients

Sham treatment + Sham treatment in patients

Arm Description

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).

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.

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).

20 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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 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 in National Institutes of Health Stroke Scale (NIHSS) in 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 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).

Full Information

First Posted
November 29, 2022
Last Updated
March 30, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Phagenesis Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05666141
Brief Title
The Effect of Pharyngeal Electrical Stimulation on Peripheral Biomechanical Aspects of Deglutition
Acronym
PES
Official Title
The Effect of Pharyngeal Electrical Stimulation (PES) on Peripheral Biomechanical Aspects of Deglutition
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Phagenesis Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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 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. 60 patients with dysphagia after acute first stroke will be included. 20 will receive PES stimulation twice, 20 will receive PES stimulation and afterwards Sham and 20 will receive Sham twice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia Following Cerebrovascular Accident, Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PES stimulation in volunteers
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham treatment in volunteers
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
PES stimulation + PES stimulation in patients
Arm Type
Experimental
Arm Description
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).
Arm Title
PES stimulation + Sham treatment in patients
Arm Type
Other
Arm Description
20 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.
Arm Title
Sham treatment + Sham treatment in patients
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Pharyngeal Electrical Stimulation
Other Intervention Name(s)
"Phagenyx"
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham treatment
Other Intervention Name(s)
Sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pressure-flow metrics
Description
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.
Time Frame
Change from Baseline at 1-2 hours, 24-72 hours and one week (only in patients) after PES/Sham intervention.
Secondary Outcome Measure Information:
Title
Functional Oral Intake Scale
Description
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.
Time Frame
Change from Baseline at 24-72 hours and one week after last PES/Sham intervention
Title
Brief Esophageal Dysphagia Questionnaire (BEDQ)
Description
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.
Time Frame
Change from Baseline at 24-72 hours and one week after last PES/Sham intervention
Title
Change in Dysphagia Severity Rating Scale (DSRS) in patients
Description
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.
Time Frame
Change from Baseline at 24-72 hours and one week after last PES/Sham intervention
Title
Change in National Institutes of Health Stroke Scale (NIHSS) in patients
Description
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.
Time Frame
Change from Baseline at 24-72 hours and one week after last PES/Sham intervention
Title
Change in Penetration-Aspiration Scale (PAS) in patients
Description
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).
Time Frame
Change from Baseline at 24-72 hours and one week after last PES/Sham intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. Exclusion Criteria volunteers: Healthy volunteers will be excluded if they: Are aged <18 years or >80 years Have (any history of) a chronic disease/medication altering the GI motility Have (any history of) gastric or gastrointestinal surgery (except appendectomy and cholecystectomy) Have (any history of) gastrointestinal disease or chronic GI symptoms (heartburn, indigestion/dyspepsia, bloating and constipation) Have a FOIS score <7 or a BEDQ score ≥ 10 at baseline Fail to provide witnessed written informed consent prior to any study procedure Inclusion Criteria patients: Dysphagic stroke patients are eligible for study participation if they: Are admitted to the hospital because of first ever acute stroke (acute means assessment within one month post stroke onset) Hemorrhagic and ischemic stroke Supratentorial and infratentorial stroke Are aged between 18 and 80 years old Are medically stable, alert or arousable Have clinical (oropharyngeal) dysphagia well identified using the FOIS/DSRS/ BEDQ/PAS at baseline. In line with earlier studies, 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 below. Exclusion Criteria patients: Patients will be excluded from study participation if: They are aged <18 years or >80 years They have an additional condition (e.g. advanced dementia) or diagnosis of a progressive neurological disorder or neuromuscular disorder that may explain dysphagia They have normal swallowing at baseline assessed with FOIS/DSRS/BEDQ/PAS They participate in any other study potentially influencing the outcome of PES, both medicinal or medical device product related and for which the patient signed a consent form for his/her study participation They receive or have received within one month prior to the intended PES treatment any form of non-invasive brain stimulation or percutaneous electrical stimulation therapy to treat dysphagia. (This is no issue, since this type of treatment is not performed at University Hospitals Leuven (UZ Leuven). It is not possible to pass a standard nasogastric tube, for example, nasal, oral or pharyngeal anatomical abnormalities that preclude passage of a feeding tube, oral intubation, history of oesophageal perforation, stricture or pouch They have a cardiac or respiratory condition that might render the insertion of a catheter into the throat unsafe (Atrial fibrillation does not render the insertion of a catheter unsafe) They have a permanently implanted electrical device They are pregnant They present with an oropharyngeal infection. This should be treated and resolved before the PES catheter is inserted They require a magnetic resonance imaging (MRI) scan during PES treatment. Insertion of the PES catheter should either be delayed until such time as the MRI has been completed, or the PES catheter should be removed and discarded and a new catheter inserted after the MRI is completed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie Rommel
Phone
+3216330483
Email
nathalie.rommel@kuleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Marthe Everaert
Phone
+3216320429
Email
marthe.everaert@kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Rommel
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaam-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Rommel
Phone
+3216330483
Email
nathalie.rommel@kuleuven.be
First Name & Middle Initial & Last Name & Degree
Marthe Everaert
Phone
+3216320429
Email
marthe.everaert@kuleuven.be

12. IPD Sharing Statement

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The Effect of Pharyngeal Electrical Stimulation on Peripheral Biomechanical Aspects of Deglutition

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