Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis: A Pilot Study With 20 Patients

During the course of ALS most patients develop swallowing deficits. In this pilot study we investigate if dysphagia in ALS can be improved by Pharyngeal Electrical Stimulation (PES). PES is Communauté Européenne (CE-) certificated and has been approved for treatment of neurological, oropharyngeal dysphagia. During PES, electrical stimuli are applied at the pharynx via a nasogastral tube with the aim of triggering reorganization processes in damaged brain structures. There is evidence of a positive effect of PES in Stroke and Multiple Sclerosis patients.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Device: Pharyngeal Electrical Stimulation

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Ulm, Germany, 89075
    • University of Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• possible, probable or definite ALS according to the revised El Escorial criteria (Brooks et al. 2000)
• age >18 years
• able to understand all information and to give full consent according to good clinical practice (GCP)
• moderate ot severe dysphagia, defined by a mean value (all consistencies) of 4

Exclusion Criteria:

• concurrent participation in another interventional trial
• tracheostomy
• severe psychiatric disorder or clinically manifest dementia
• pulmonal or cardial disorder which constitutes a risk when inserting the tube into the pharynx
• permanent cardiac pacemaker or defibrillator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharyngeal Electrical Stimulation; PES for 10 minutes per day on 3 consecutive days in addition to standard therapy (logopedic counselling, advice for nutrition, learning of swallowing techniques)	Device: Pharyngeal Electrical Stimulation; Pharyngeal Electrical Stimulation is applied at the pharynx via a nasogastral tube for 10 minutes per day on 3 consecutive days.
No Intervention: Control; Standard therapy (logopedic counselling, advice for nutrition, learning of swallowing techniques)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penetration Aspiration Scale (PAS) Score	Degree of Penetration and Aspiration evaluated by fiberendoscopic evaluation of swallowing (FEES)	day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing-Quality of Life Score (SWAL-QOL)	swallowing-specific quality of life questionnaire	day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Schluckbeeinträchtigungs-Skala (SBS) Score	Clinical scale to evaluate severity of dysphagia	day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Functional Oral Intake Scale (FOIS) Score	Clinical scale to evaluate the impairment of oral food intake	day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Dysphagia Severity Rating Scale (DSRS) Score	Clinical scale to evaluate severity of dysphagia	day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALS-FRS-R)	Clinical scale to evaluate the severity of symptoms in ALS	day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Frequency of Adverse Events	Frequency of Adverse Events	day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90

Collaborators and Investigators

• Sponsor: University of Ulm

Publications and helpful links

General Publications

• Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. doi: 10.1080/146608200300079536. No abstract available.
• Herrmann C, Schradt F, Lindner-Pfleghar B, Schuster J, Ludolph AC, Dorst J. Pharyngeal electrical stimulation in amyotrophic lateral sclerosis: a pilot study. Ther Adv Neurol Disord. 2022 Feb 8;15:17562864211068394. doi: 10.1177/17562864211068394. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): July 21, 2020
• Study Completion (Actual): July 21, 2020

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: PES-ALS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No