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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharyngeal Electrical Stimulation | Experimental | PES for 10 minutes per day on 3 consecutive days in addition to standard therapy (logopedic counselling, advice for nutrition, learning of swallowing techniques) |
|
| Control | No Intervention | Standard therapy (logopedic counselling, advice for nutrition, learning of swallowing techniques) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharyngeal Electrical Stimulation | Device | Pharyngeal Electrical Stimulation is applied at the pharynx via a nasogastral tube for 10 minutes per day on 3 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Penetration Aspiration Scale (PAS) Score | Degree of Penetration and Aspiration evaluated by fiberendoscopic evaluation of swallowing (FEES) | day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Swallowing-Quality of Life Score (SWAL-QOL) | swallowing-specific quality of life questionnaire | day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90 |
| Schluckbeeinträchtigungs-Skala (SBS) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ulm | Ulm | 89075 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11464847 | Background | 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. | |
| 35154390 |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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Clinical scale to evaluate severity of dysphagia
| day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90 |
| Functional Oral Intake Scale (FOIS) Score | Clinical scale to evaluate the impairment of oral food intake | day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90 |
| Dysphagia Severity Rating Scale (DSRS) Score | Clinical scale to evaluate severity of dysphagia | day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90 |
| Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALS-FRS-R) | Clinical scale to evaluate the severity of symptoms in ALS | day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90 |
| Frequency of Adverse Events | Frequency of Adverse Events | day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90 |
| 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. |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |