Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

NCT ID: NCT03481348

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-07-21

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 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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pharyngeal Electrical Stimulation

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

Group Type: EXPERIMENTAL

Pharyngeal Electrical Stimulation

Intervention Type: DEVICE

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pharyngeal Electrical Stimulation

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Albert Christian Ludolph, Prof.

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Ulm

Ulm, , Germany

Countries

Germany

References

Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. doi: 10.1080/146608200300079536. No abstract available.

Reference Type: BACKGROUND

PMID: 11464847 (View on PubMed)

Herrmann C, Schradt F, Lindner-Pfleghar B, Schuster J, Ludolph AC, Dorst J. Pharyngeal electrical stimulation in amyotrophic lateral sclerosis: a pilot study. Ther Adv Neurol Disord. 2022 Feb 8;15:17562864211068394. doi: 10.1177/17562864211068394. eCollection 2022.

Reference Type: DERIVED

PMID: 35154390 (View on PubMed)

Other Identifiers

PES-ALS

Identifier Type: -

Identifier Source: org_study_id