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
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Device
Intervention Name:
Pharyngeal Electrical Stimulation
Placebo:
Phase:
Phase 1/Phase 2
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Study Sponsor:
University of Ulm
Estimated Enrollment:
20
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 neals.org:
03 / 29 / 2018
Minimum Age:
18 Years
Maximum Age:
N/A
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
Germany