The Effect of Pharyngeal Electrical Stimulation on Peripheral Biomechanical Aspects of Deglutition
NCT ID: NCT05666141
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
84 participants
INTERVENTIONAL
2022-06-07
2025-09-30
Brief Summary
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The peripheral effect of PES intervention on the biomechanics of swallowing will be evaluated with High Resolution Manometry Impedance (HRMI).
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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PES stimulation in volunteers
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).
Pharyngeal Electrical Stimulation
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.
Sham treatment in volunteers
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.
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.
PES stimulation + PES stimulation in stroke patients
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).
Pharyngeal Electrical Stimulation
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.
PES stimulation + Sham treatment in stroke patients
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.
Pharyngeal Electrical Stimulation
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.
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.
Sham treatment + Sham treatment in stroke patients
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.
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.
PES stimulation + PES stimulation in ICU patients
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).
Pharyngeal Electrical Stimulation
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.
Sham treatment + Sham treatment in ICU patients
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.
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.
Interventions
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Pharyngeal Electrical Stimulation
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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)
* Hemorrhagic and ischemic stroke
* Supratentorial and infratentorial stroke or have post-extubation dysphagia (PED) due to recent extubation following invasive mechanical ventilation (of any duration) by means of endotracheal tube or received (prolonged) intensive-care unit treatment leading to critical illness dysphagia due to (clinical suspicion of) critical illness polyneuropathy (CIP) and myopathy (CIM)
* 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
Exclusion Criteria
* 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
Patients will be excluded from study participation if:
* They are aged \<18 years or \>85 years
* They have pre-existing neurogenic dysphagia or a condition that can cause dysphagia (e.g. advanced dementia, Parkinson's Disease, myasthenia gravis, motor neuron disease…);
* They have pre-existing non-neurogenic dysphagia (e.g. cancer, …);
* They have normal swallowing at baseline assessed with FOIS/DSRS/BEDQ/PAS
* When they participate in another interventional study, they must inform the researcher or study staff. They agree not to participate in another study simultaneously without having informed the researcher or study staff, and that participation may be refused for justified reasons.
* 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.)
* It is not possible to pass a standard nasogastric tube, for example, nasal, oral, pharyngeal or oesophageal anatomical abnormalities that preclude passage of a feeding tube, oral intubation, history of oesophageal perforation, stricture, pouch or resection, maxillofacial surgery, partial or total laryngectomy
* They have a cardiac or respiratory condition that might render the insertion of a catheter into the throat unsafe (Severe heart failure, end stage chronic obstructive pulmonary disease (COPD). 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 an 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
18 Years
85 Years
ALL
Yes
Sponsors
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Phagenesis Ltd.
INDUSTRY
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Nathalie Rommel
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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UZ Leuven
Leuven, Vlaam-Brabant, Belgium
Countries
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Central Contacts
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Facility Contacts
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Nathalie Rommel
Role: primary
Marthe Everaert
Role: backup
Other Identifiers
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S65439
Identifier Type: -
Identifier Source: org_study_id