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

Exclusion Criteria20

• 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
• 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