Clinical trial NCT03481348: Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis
Official title: Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis: A Pilot Study With 20 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Penetration Aspiration Scale (PAS) Score
timeFrame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Secondary outcomes:
measure: Swallowing-Quality of Life Score (SWAL-QOL)
timeFrame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
measure: Schluckbeeinträchtigungs-Skala (SBS) Score
timeFrame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
measure: Functional Oral Intake Scale (FOIS) Score
timeFrame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
measure: Dysphagia Severity Rating Scale (DSRS) Score
timeFrame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
measure: Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALS-FRS-R)
timeFrame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
measure: Frequency of Adverse Events
timeFrame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University of Ulm
Study officials:
References:
citation: 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. doi: 10.1080/146608200300079536. No abstract available.
citation: Herrmann C, Schradt F, Lindner-Pfleghar B, Schuster J, Ludolph AC, Dorst J. Pharyngeal electrical stimulation in amyotrophic lateral sclerosis: a pilot study. Ther Adv Neurol Disord. 2022 Feb 8;15:17562864211068394. doi: 10.1177/17562864211068394. eCollection 2022.