NCT05666141

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

The Effect of Pharyngeal Electrical Stimulation (PES) on Peripheral Biomechanical Aspects of Deglutition

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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).

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.

Conditions

• Dysphagia Following Cerebrovascular Accident
• Dysphagia

Interventions

Type	Name	Description
DEVICE	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.
OTHER	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.

Timeline

• Start date: 2022-06-07
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2022-12-27
• Last updated: 2024-12-10

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study