Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

University of Ulm20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Pharyngeal Electrical StimulationDEVICE

Pharyngeal Electrical Stimulation is applied at the pharynx via a nasogastral tube for 10 minutes per day on 3 consecutive days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Ulm

Ulm, Germany