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

Study Purpose:

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 Status:

Not recruiting


Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:


Intervention Name:

Pharyngeal Electrical Stimulation



Phase 1/Phase 2

Study Chair(s)/Principal Investigator(s):



Neals Affiliated?


Coordinating Center Contact Information

Study Sponsor:

University of Ulm

Estimated Enrollment:


Estimated Study Start Date:

02 / 01 / 2018

Estimated Study Completion Date:

07 / 21 / 2020

Posting Last Modified Date:

03 / 08 / 2021

Date Study Added to

03 / 29 / 2018

Minimum Age:

18 Years

Maximum Age:


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

University of Ulm

Ulm 89075