Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03481348
• Other study ID #: PES-ALS
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 1, 2018
• Est. completion date: July 21, 2020

Study information

• Verified date: March 2021
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 21, 2020
• Est. primary completion date: July 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Germany	University of Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Frequency of Adverse Events	Frequency of Adverse Events	day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90