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Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT03481348
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Albert Christian Ludolph, Prof., University of Ulm

Tracking Information
First Submitted Date  ICMJE March 8, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE February 1, 2018
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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
  • Frequency of Adverse Events [ Time Frame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90 ]
    Frequency of Adverse Events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis
Official Title  ICMJE Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis: A Pilot Study With 20 Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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)
    Intervention: Device: Pharyngeal Electrical Stimulation
  • No Intervention: Control
    Standard therapy (logopedic counselling, advice for nutrition, learning of swallowing techniques)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 26, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03481348
Other Study ID Numbers  ICMJE PES-ALS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Albert Christian Ludolph, Prof., University of Ulm
Study Sponsor  ICMJE University of Ulm
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Ulm
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP