Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03481348
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Albert Christian Ludolph, Prof., 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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: Pharyngeal Electrical Stimulation Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis: A Pilot Study With 20 Patients
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : August 1, 2019


Arm Intervention/treatment
Experimental: 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)
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.

No Intervention: Control
Standard therapy (logopedic counselling, advice for nutrition, learning of swallowing techniques)



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481348


Locations
Layout table for location information
Germany
University of Ulm Recruiting
Ulm, Germany, 89075
Contact: Johannes Dorst, MD    +49 731 177 ext 5285    johannes.dorst@uni-ulm.de   
Principal Investigator: Johannes Dorst, MD         
Sponsors and Collaborators
University of Ulm

Publications:
Layout table for additonal information
Responsible Party: Albert Christian Ludolph, Prof., Prof., University of Ulm
ClinicalTrials.gov Identifier: NCT03481348     History of Changes
Other Study ID Numbers: PES-ALS
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases