Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

NCT03481348 | Completed Phase 1

• 1 other identifier: PES-ALS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Penetration Aspiration Scale (PAS) Score

  Degree of Penetration and Aspiration evaluated by fiberendoscopic evaluation of swallowing (FEES)

  day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90

Secondary Outcomes (6)

• Swallowing-Quality of Life Score (SWAL-QOL)

  day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90

• Schluckbeeinträchtigungs-Skala (SBS) Score

  day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90

• Functional Oral Intake Scale (FOIS) Score

  day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90

• Dysphagia Severity Rating Scale (DSRS) Score

  day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90

• Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALS-FRS-R)

  day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90

Study Arms (2)

Pharyngeal Electrical Stimulation

EXPERIMENTAL

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

Device: Pharyngeal Electrical Stimulation

Control

NO INTERVENTION

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

Interventions

Pharyngeal Electrical Stimulation DEVICE

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

Pharyngeal Electrical Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

University of Ulm

Ulm, 89075, Germany

Location

Related Publications (2)

• 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.

  PMID: 11464847 BACKGROUND

• 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.

  PMID: 35154390 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 29, 2018
• Study Start: February 1, 2018
• Primary Completion: July 21, 2020
• Study Completion: July 21, 2020
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)