NCT05666141|UnknownFDA Device
The Effect of Pharyngeal Electrical Stimulation on Peripheral Biomechanical Aspects of Deglutition
PES
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PES
Sponsor study identifier
interventional
84
1 country
1
Study Start
June 7, 2022
Actual (reported)Primary Completion
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 7, 2022
Actual (reported)November 29, 2022
Actual (reported)December 27, 2022
Actual (reported)September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Change from Baseline at 1-2 hours, 24-72 hours and one week (only in patients) after PES/Sham intervention.
Functional Oral Intake Scale
Change from Baseline at 24-72 hours and one week after last PES/Sham intervention
Brief Esophageal Dysphagia Questionnaire (BEDQ)
Change from Baseline at 24-72 hours and one week after last PES/Sham intervention
Change in Dysphagia Severity Rating Scale (DSRS) in patients
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
Change from Baseline at 24-72 hours and one week after last PES/Sham intervention
Change in Penetration-Aspiration Scale (PAS) in patients
Change from Baseline at 24-72 hours and one week after last PES/Sham intervention
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).
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.
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.
UZ Leuven
Leuven, Vlaam-Brabant, 3000, Belgium
Nathalie Rommel
Universitaire Ziekenhuizen KU Leuven
First Submitted
November 29, 2022
First Posted
December 27, 2022
Study Start
June 7, 2022
Actual (reported)Primary Completion
September 2025
Estimated (date passed)Effect of Stellate Nerve Block in Dysphagia
The Aspirometer: A Noninvasive Tool for Detecting Aspiration Aim 3
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).
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.
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.
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).
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.
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.
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Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 10, 2024
Record last verified: 2024-05
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