Status:
COMPLETED
Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis
Lead Sponsor:
University of Ulm
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03481348
Start Date
February 1 2018
End Date
July 21 2020
Last Update
March 8 2021
Active Locations (1)
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1
University of Ulm
Ulm, Germany, 89075