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Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Pharyngeal Electrical Stimulation

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pharyngeal Electrical Stimulation

Control

Arm 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)

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

Outcomes

Primary Outcome Measures

Penetration Aspiration Scale (PAS) Score

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

Secondary Outcome Measures

Swallowing-Quality of Life Score (SWAL-QOL)

swallowing-specific quality of life questionnaire

Schluckbeeinträchtigungs-Skala (SBS) Score

Clinical scale to evaluate severity of dysphagia

Functional Oral Intake Scale (FOIS) Score

Clinical scale to evaluate the impairment of oral food intake

Dysphagia Severity Rating Scale (DSRS) Score

Clinical scale to evaluate severity of dysphagia

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

Clinical scale to evaluate the severity of symptoms in ALS

Frequency of Adverse Events

Full Information

NCT ID

NCT03481348

First Posted

March 8, 2018

Last Updated

March 5, 2021

Sponsor

University of Ulm

1. Study Identification

Unique Protocol Identification Number

NCT03481348

Brief Title

Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

Official Title

Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis: A Pilot Study With 20 Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

February 1, 2018 (Actual)

Primary Completion Date

July 21, 2020 (Actual)

Study Completion Date

July 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Ulm

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pharyngeal Electrical Stimulation

Arm Type

Experimental

Arm 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)

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Pharyngeal Electrical Stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Penetration Aspiration Scale (PAS) Score

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Swallowing-Quality of Life Score (SWAL-QOL)

Description

swallowing-specific quality of life questionnaire

Time Frame

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

Title

Schluckbeeinträchtigungs-Skala (SBS) Score

Description

Clinical scale to evaluate severity of dysphagia

Time Frame

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

Title

Functional Oral Intake Scale (FOIS) Score

Description

Clinical scale to evaluate the impairment of oral food intake

Time Frame

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

Title

Dysphagia Severity Rating Scale (DSRS) Score

Description

Clinical scale to evaluate severity of dysphagia

Time Frame

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

Title

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

Description

Clinical scale to evaluate the severity of symptoms in ALS

Time Frame

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

Title

Frequency of Adverse Events

Description

Frequency of Adverse Events

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

University of Ulm

City

Ulm

ZIP/Postal Code

89075

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

11464847

Citation

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.

Results Reference

background

PubMed Identifier

35154390

Citation

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.

Results Reference

derived

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Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

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