Dysphagia Following Cerebrovascular AccidentPESNCT05666141
The Effect of Pharyngeal Electrical Stimulation on Peripheral Biomechanical Aspects of Deglutition
A study testing Pharyngeal Electrical Stimulation in people with Dysphagia Following Cerebrovascular Accident and Dysphagia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia Following Cerebrovascular Accident, Dysphagia
- What is being tested?
- Pharyngeal Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Jun 2022to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- Provide witnessed written informed consent prior to any study procedure And if they do not meet any of the exclusion criteria listed below.
- 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
- Give (or have a witness to give) voluntary written informed consent And if they do not meet any of the exclusion criteria listed hereunder.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaam-Brabant, 3000
Nathalie Rommel, +3216330483, nathalie.rommel@kuleuven.be
Marthe Everaert, +3216320429, marthe.everaert@kuleuven.be
About this study
Official title: The Effect of Pharyngeal Electrical Stimulation (PES) on Peripheral Biomechanical Aspects of Deglutition
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).
Read the 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.
- Being tested
- Pharyngeal Electrical Stimulation, Sham treatment
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharyngeal Electrical StimulationDevice
Also called "Phagenyx"
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 treatmentOther
Also called Sham
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Pharyngeal Electrical Stimulation |
| 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. Receives: Other: Sham treatment |
| 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). Receives: Device: Pharyngeal Electrical Stimulation |
| 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. Receives: Device: Pharyngeal Electrical Stimulation; Other: Sham treatment |
| 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. Receives: Other: Sham treatment |
| 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). Receives: Device: Pharyngeal Electrical Stimulation |
| 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. Receives: Other: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline at 1-2 hours, 24-72 hours and one week (only in patients) after PES/Sham intervention.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Change from Baseline at 24-72 hours and one week after last PES/Sham intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start7 Jun 2022
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia Following Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Phagenesis Ltd.
- Responsible party
- Sponsor
- Investigators
- Nathalie Rommel, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666141
- Sponsor's protocol ID
- S65439
- Acronym
- PES
- Status last verified
- May 2024
- First submitted
- 29 Nov 2022
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pharyngeal Electrical Stimulation (PES) on Peripheral Biomechanical Aspects of Deglutition
- ClinicalTrials.gov ID
- NCT05666141
- Acronym / sponsor ID
- PES / S65439
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Phagenesis Ltd.
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| PES stimulation in volunteers | Experimental | Device: Pharyngeal Electrical Stimulation10 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). |
| Sham treatment in volunteers | Sham comparator | Other: Sham treatment10 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. |
| PES stimulation + PES stimulation in stroke patients | Experimental | Device: Pharyngeal Electrical StimulationMax 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). |
| PES stimulation + Sham treatment in stroke patients | Other | Device: Pharyngeal Electrical Stimulation, Other: Sham treatmentMax 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. |
| Sham treatment + Sham treatment in stroke patients | Sham comparator | Other: Sham treatmentMax 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. |
| PES stimulation + PES stimulation in ICU patients | Experimental | Device: Pharyngeal Electrical StimulationMax 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 | Other: Sham treatmentMax 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharyngeal Electrical StimulationAlso: "Phagenyx"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. | Device | PES stimulation + PES stimulation in ICU patients, PES stimulation + PES stimulation in stroke patients, PES stimulation + Sham treatment in stroke patients, PES stimulation in volunteers |
| Sham treatmentAlso: ShamIn 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 | PES stimulation + Sham treatment in stroke patients, Sham treatment + Sham treatment in ICU patients, Sham treatment + Sham treatment in stroke patients, Sham treatment in volunteers |
Primary outcome
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.
5 secondary outcomes
Functional Oral Intake Scale
Time frame: Change from Baseline at 24-72 hours and one week after last PES/Sham intervention
Brief Esophageal Dysphagia Questionnaire (BEDQ)
Time frame: Change from Baseline at 24-72 hours and one week after last PES/Sham intervention
Change in Dysphagia Severity Rating Scale (DSRS) in patients
Time frame: 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
Time frame: Change from Baseline at 24-72 hours and one week after last PES/Sham intervention
Change in Penetration-Aspiration Scale (PAS) in patients
Time frame: Change from Baseline at 24-72 hours and one week after last PES/Sham intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Rommel principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharyngeal Electrical Stimulation in people with Dysphagia Following Cerebrovascular Accident and Dysphagia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathalie Rommel (+3216330483, nathalie.rommel@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.