UnknownNot Applicable

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

Belgium84 participantsStarted 2022-06-07

Plain-language 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).

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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 infratent…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in pressure-flow metrics

Timeframe: Change from Baseline at 1-2 hours, 24-72 hours and one week (only in patients) after PES/Sham intervention.

Trial details

NCT IDNCT05666141

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09

Contact for this trial

Nathalie Rommel

+3216330483 nathalie.rommel@kuleuven.be

View on ClinicalTrials.gov More Dysphagia Following Cerebrovascular Accident trials