Actively Recruiting
The Effect of Pharyngeal Electrical Stimulation on Peripheral Biomechanical Aspects of Deglutition
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-12-10
84
Participants Needed
1
Research Sites
168 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
P
Phagenesis Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
The Effect of Pharyngeal Electrical Stimulation on Peripheral Biomechanical Aspects of Deglutition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 18 to 80 years
- No history of chronic disease or medication affecting gastrointestinal motility
- No history of gastric or gastrointestinal surgery except appendectomy and cholecystectomy
- No history of gastrointestinal disease or chronic gastrointestinal symptoms such as heartburn, indigestion, bloating, or constipation
- FOIS score of 7 or BEDQ score less than 10 at baseline
- Provide witnessed written informed consent prior to any study procedure
- Patients admitted with acute stroke assessed within one month post onset, including hemorrhagic or ischemic stroke, or post-extubation dysphagia due to recent extubation or critical illness polyneuropathy/myopathy
- Patients aged between 18 and 85 years
- Medically stable, alert or arousable (NIHSS 0/1 for stroke; RASS -1/0/+1 and ICDSC less than 4 for ICU patients)
- Clinical oropharyngeal dysphagia identified by standardized scoring (DSRS score 6 or higher; FOIS score 5 or lower; BEDQ score 10 or higher; or PAS score 4 or higher when no oral intake possible)
- Provide voluntary written informed consent or have a witness to consent
You will not qualify if you...
- Age under 18 or over 80 years for volunteers; under 18 or over 85 years for patients
- History of chronic disease or medication altering gastrointestinal motility
- History of gastric or gastrointestinal surgery except appendectomy and cholecystectomy
- History of gastrointestinal disease or chronic GI symptoms such as heartburn, indigestion, bloating, or constipation
- FOIS score less than 7 or BEDQ score 10 or higher at baseline for volunteers
- Failure to provide witnessed written informed consent
- Pre-existing neurogenic dysphagia or conditions causing dysphagia such as advanced dementia, Parkinson's disease, myasthenia gravis, motor neuron disease
- Pre-existing non-neurogenic dysphagia such as cancer
- Normal swallowing at baseline assessed by standard scores
- Participation in another interventional study without informing researchers
- Receipt of non-invasive brain stimulation or percutaneous electrical stimulation for dysphagia within one month prior to PES treatment
- Inability to pass a standard nasogastric tube due to anatomical abnormalities or prior surgeries
- Cardiac or respiratory conditions making catheter insertion unsafe (severe heart failure, end-stage COPD)
- Presence of permanently implanted electrical devices
- Pregnancy
- Oropharyngeal infection requiring treatment before catheter insertion
- Need for MRI during PES treatment without ability to delay or remove catheter
AI-Screening
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Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Vlaam-Brabant, Belgium, 3000
Actively Recruiting
Research Team
N
Nathalie Rommel
CONTACT
M
Marthe Everaert
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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