Interventional {{label}}

Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

Please note: All trial information reflects the latest data available from the sponsor on ClinicalTrials.gov and other public databases. However, these sources may occasionally be outdated or inaccurate. For the most current information, we recommend contacting the trial sponsor or sites directly.

Overview

Intervention or Drug Name

Sponsor

Trial Status

Phase

Randomization

Trial Duration

Route of Administration

Genetic Target

Repurposed Drugs

Approved by FDA

Approved outside USA

Is a supplement

Details

Enrollment Criteria

Time since symptom onset

Vital Capacity (FVC or SVC)

Approved Medications

Registry Listing

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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.

What participation looks like

Eligibility criteria

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

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