Amyotrophic Lateral Sclerosis
Conditions
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.
Interventions
Pharyngeal Electrical Stimulation is applied at the pharynx via a nasogastral tube for 10 minutes per day on 3 consecutive days.
Sponsors
University of Ulm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Penetration Aspiration Scale (PAS) Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Schluckbeeinträchtigungs-Skala (SBS) Score | 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 | day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90 | Clinical scale to evaluate the impairment of oral food intake |
| Swallowing-Quality of Life Score (SWAL-QOL) | day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90 | swallowing-specific quality of life questionnaire |
| Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALS-FRS-R) | 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 | day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90 | Frequency of Adverse Events |
| Dysphagia Severity Rating Scale (DSRS) Score | day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90 | Clinical scale to evaluate severity of dysphagia |
Countries
Germany
Outcome results
None listed