Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

University of Ulm

Status and phase: Completed; Phase 2; Phase 1

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Device: Pharyngeal Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03481348

PES-ALS

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Pharyngeal Electrical Stimulation

Experimental group

Description:

PES for 10 minutes per day on 3 consecutive days in addition to standard therapy (logopedic counselling, advice for nutrition, learning of swallowing techniques)

Treatment:

Device: Pharyngeal Electrical Stimulation

Control

No Intervention group

Description:

Standard therapy (logopedic counselling, advice for nutrition, learning of swallowing techniques)