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Completed

NCT Number: NCT03481348

Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Ulm

Ulm, 89075, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Penetration Aspiration Scale (PAS) Score

    Time frame: 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 outcomes

  1. Swallowing-Quality of Life Score (SWAL-QOL)

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

    swallowing-specific quality of life questionnaire

  2. Schluckbeeinträchtigungs-Skala (SBS) Score

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

    Clinical scale to evaluate severity of dysphagia

  3. Functional Oral Intake Scale (FOIS) Score

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

    Clinical scale to evaluate the impairment of oral food intake

  4. Dysphagia Severity Rating Scale (DSRS) Score

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

    Clinical scale to evaluate severity of dysphagia

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

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

    Clinical scale to evaluate the severity of symptoms in ALS

  6. Frequency of Adverse Events

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

    Frequency of Adverse Events

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 29, 2018
Registry last updated
Mar 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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