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

NCT05666141 | Recruiting FDA Device

• 1 other identifier: S65439
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dysphagia Following Cerebrovascular Accident; Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• 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

Study Arms (7)

PES stimulation in volunteers

EXPERIMENTAL

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).

Device: Pharyngeal Electrical Stimulation

Sham treatment in volunteers

SHAM COMPARATOR

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.

Other: Sham treatment

PES stimulation + PES stimulation in stroke patients

EXPERIMENTAL

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).

Device: Pharyngeal Electrical Stimulation

PES stimulation + Sham treatment in stroke patients

OTHER

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.

Device: Pharyngeal Electrical Stimulation; Other: Sham treatment

Sham treatment + Sham treatment in stroke patients

SHAM COMPARATOR

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.

Other: Sham treatment

PES stimulation + PES stimulation in ICU patients

EXPERIMENTAL

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).

Device: Pharyngeal Electrical Stimulation

Sham treatment + Sham treatment in ICU patients

EXPERIMENTAL

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.

Other: Sham treatment

Interventions

Pharyngeal Electrical Stimulation DEVICE

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.

Also known as: "Phagenyx"

PES stimulation + PES stimulation in ICU patients; PES stimulation + PES stimulation in stroke patients; PES stimulation + Sham treatment in stroke patients; PES stimulation in volunteers

Sham treatment OTHER

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.

Also known as: Sham

PES stimulation + Sham treatment in stroke patients; Sham treatment + Sham treatment in ICU patients; Sham treatment + Sham treatment in stroke patients; Sham treatment in volunteers

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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 infratentorial stroke or have post-extubation dysphagia (PED) due to recent extubation following invasive mechanical ventilation (of any duration) by means of endotracheal tube or received (prolonged) intensive-care unit treatment leading to critical illness dysphagia due to (clinical suspicion of) critical illness polyneuropathy (CIP) and myopathy (CIM)
• Are aged between 18 and 85 years old
• Are medically stable, alert or arousable (Stroke: National Institutes of Health Stroke Scale (NIHSS) 0/1, ICU: Richmond Agitation-Sedation Scale (RASS) -1/0/+1 and Intensive Care Delirium Screening Checklist (ICDSC) \<4)
• Have clinical (oropharyngeal) dysphagia well identified using the FOIS/DSRS/ BEDQ/PAS at baseline. In line with earlier studies(16,27), we use the following criteria: a DSRS score of 6 or higher; or a FOIS-score equal to or lower than 5; or a BEDQ score of 10 or higher or (when no oral food intake is possible and DSRS score is 12/FOIS score is 1) a PAS-score of 4 or higher
• Patients will be excluded from study participation if:

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Phagenesis Ltd.: collaborator

Study Sites (1)

UZ Leuven

Leuven, Vlaam-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Nathalie Rommel

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Rommel

CONTACT

+3216330483; nathalie.rommel@kuleuven.be

Marthe Everaert

CONTACT

+3216320429; marthe.everaert@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 27, 2022
• Study Start: June 7, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-05

Locations

BE (1)