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. 2022 Feb 8:15:17562864211068394.
doi: 10.1177/17562864211068394. eCollection 2022.

Pharyngeal electrical stimulation in amyotrophic lateral sclerosis: a pilot study

Christine Herrmann  1 , Falk Schradt  1 , Beate Lindner-Pfleghar  1 , Joachim Schuster  1 , Albert C Ludolph  1 , Johannes Dorst  2
Affiliations

Pharyngeal electrical stimulation in amyotrophic lateral sclerosis: a pilot study

Christine Herrmann et al. Ther Adv Neurol Disord. .

Abstract

Background: Patients with amyotrophic lateral sclerosis (ALS) suffer from dysphagia that increases the risk for aspiration, pneumonia and weight loss. Pharyngeal electrical stimulation (PES) is a therapeutic technique that applies electric stimuli to the patient's pharynx in order to improve swallowing based on the principle of cortical plasticity and reorganization. Previous studies have demonstrated positive effects in patients with various neurological diseases.

Objective: This study was initiated to investigate the effect of PES on swallowing function in patients with ALS.

Methods: In all, 20 ALS patients with severe dysphagia [characterized by a Penetration Aspiration Scale (PAS) of at least 4 in thin liquid] were randomized to receive either PES for 10 min at 3 consecutive days in addition to Standard Logopaedic Therapy (SLT) or SLT alone. Swallowing function was evaluated by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) at five timepoints: at baseline, 1 day, 4 days, 3 weeks and 3 months after treatment. Primary endpoint was the severity of penetrations or aspirations as classified by PAS. Secondary endpoints were adverse events, dysphagia-related quality of life, Swallowing Quality of Life (SWAL-QOL), Dysphagia Severity Rating Scale (DSRS), residues, leaking, ALS Functional Rating Scale Revised (ALSFRS-R), and the performance in Clinical Evaluation of Swallowing (CES). The trial is registered under the name of 'Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis' with ClinialTrials.gov, number NCT03481348 (https://clinicaltrials.gov/ct2/show/NCT03481348).

Results: Both groups combined showed a significant improvement (p = 0.003) of median Total-PAS from 3.6 [interquartile range (IQR) = 2.9-5.0] at baseline to 2.3 (IQR = 1.8-4.0) 1 day after treatment. During subsequent study visits, PAS increased again but remained below baseline. PES and control group did not differ significantly 1 day after intervention (p = 0.32). Similar effects were found in the majority of secondary endpoints.

Interpretation: The findings suggest that PES may not provide an additional positive effect on swallowing function in ALS. SLT seems to yield at least short-term positive effects on swallowing function and swallowing-specific life quality in ALS.Registration: ClinialTrials.gov: NCT03481348.

Keywords: Fiberoptic Endoscopic Evaluation of Swallowing; amyotrophic lateral sclerosis; logopaedic therapy; pharyngeal electrical stimulation.

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Conflict of interest statement

Conflict of interest statement: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Total-PAS in whole study population. BL, baseline; d1, 1 day after treatment; d4, 4 days after treatment; m3, 3 months after treatment; PAS, Penetration Aspiration Scale; w3, 3 weeks after treatment.
Figure 2.
Figure 2.
Total-PAS in PES and control group. BL, baseline; d1, 1 day after treatment; d4, 4 days after treatment; m3, 3 months after treatment; PAS, Penetration Aspiration Scale; PES, pharyngeal electrical stimulation; w3, 3 weeks after treatment.
Figure 3.
Figure 3.
Swallowing function (blue-coloured water) before (BL) and after treatment (d1). The figure shows the penetration and aspiration findings evaluated by FEES in a patient receiving PES before and 1 day after completed treatment (=3 sessions of PES) during a swallowing test with a teaspoon of blue-coloured water. Above: silent aspiration (*) in the trachea (1) without ejection from the airway (PAS = 8) at baseline. Below: penetration of water (*) into the airways but remaining above the vocal folds (2) (PAS = 3) 1 day after completed treatment (=3 sessions of PES). BL, baseline; d1, 1 day after treatment; FEES, Fiberoptic Endoscopic Evaluation of Swallowing; PAS, Penetration Aspiration Scale.
Figure 4.
Figure 4.
Erythema at the pharyngeal wall after PES. The figure shows an erythema after PES in FEES 1 day after treatment that diminished 5 days after treatment. Left: erythema (*) 1 day after intervention. Right: diminishing erythema 5 days after intervention. FEES, Fiberoptic Endoscopic Evaluation of Swallowing; PES, pharyngeal electrical stimulation.
See this image and copyright information in PMC

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