Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis: A Pilot Study With 20 Patients
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Amyotrophic Lateral Sclerosis
- Sponsor
- University of Ulm
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Penetration Aspiration Scale (PAS) Score
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Albert Christian Ludolph, Prof.
Prof.
University of Ulm
Eligibility 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
Outcomes
Primary Outcomes
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
- Swallowing-Quality of Life Score (SWAL-QOL)(day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90)
- Functional Oral Intake Scale (FOIS) Score(day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90)
- Schluckbeeinträchtigungs-Skala (SBS) Score(day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90)
- Dysphagia Severity Rating Scale (DSRS) Score(day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90)
- Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALS-FRS-R)(day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90)
- Frequency of Adverse Events(day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90)