Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

Phase 1

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Device: Pharyngeal Electrical Stimulation

• Registration Number: NCT03481348
• Lead Sponsor: University of Ulm

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-03-29
• Primary Completion: 2020-07-21
• Study Completion: 2020-07-21
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharyngeal Electrical Stimulation	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)

Primary Outcome Measures

Name	Time	Method
Penetration Aspiration Scale (PAS) Score	day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90	Degree of Penetration and Aspiration evaluated by fiberendoscopic evaluation of swallowing (FEES)

Secondary Outcome Measures

Name	Time	Method
Swallowing-Quality of Life Score (SWAL-QOL)	day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90	swallowing-specific quality of life questionnaire
Schluckbeeinträchtigungs-Skala (SBS) Score	day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90	Clinical scale to evaluate severity of dysphagia
Functional Oral Intake Scale (FOIS) Score	day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90	Clinical scale to evaluate the impairment of oral food intake
Dysphagia Severity Rating Scale (DSRS) Score	day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90	Clinical scale to evaluate severity of dysphagia
Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALS-FRS-R)	day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90	Clinical scale to evaluate the severity of symptoms in ALS
Frequency of Adverse Events	day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90	Frequency of Adverse Events

Trial Locations

Locations (1)

University of Ulm; 🇩🇪 Ulm, Germany