Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

Study Overview
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Brief Summary
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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.

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

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Device: Pharyngeal Electrical Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharyngeal Electrical Stimulation<br>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<br>* Pharyngeal Electrical Stimulation is applied at the pharynx via a nasogastral tube for 10 minutes per day on 3 consecutive days.<br>|
| No Intervention: Control<br>Standard therapy (logopedic counselling, advice for nutrition, learning of swallowing techniques) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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