Pharyngeal electrical stimulation for neurogenic dysphagia following stroke, traumatic brain injury or other causes: Main results from the PHADER cohort study

Background: Neurogenic dysphagia is common and has no definitive treatment. We assessed whether pharyngeal electrical stimulation (PES) is associated with reduced dysphagia. Methods: The PHAryngeal electrical stimulation for treatment of neurogenic Dysphagia European Registry (PHADER) was a prospective single-arm observational cohort study. Participants were recruited with neurogenic dysphagia (comprising five groups - stroke not needing ventilation; stroke needing ventilation; ventilation acquired; traumatic brain injury; other neurological causes). PES was administered once daily for three days. The primary outcome was the validated dysphagia severity rating scale (DSRS, score best-worst 0-12) at 3 months. Findings: Of 255 enrolled patients from 14 centres in Austria, Germany and UK, 10 failed screening. At baseline, mean (standard deviation) or median [interquartile range]: age 68 (14) years, male 71%, DSRS 11.4 (1.7), time from onset to treatment 32 [44] days; age, time and DSRS differed between diagnostic groups. Insertion of PES catheters was successfully inserted in 239/245 (98%) participants, and was typically easy taking 11.8 min. 9 participants withdrew before the end of treatment. DSRS improved significantly in all dysphagia groups, difference in means (95% confidence intervals, CI) from 0 to 3 months: stroke (n = 79) -6.7 (-7.8, -5.5), ventilated stroke (n = 98) -6.5 (-7.6, -5.5); ventilation acquired (n = 35) -6.6 (-8.4, -4.8); traumatic brain injury (n = 24) -4.5 (-6.6, -2.4). The results for DSRS were mirrored for instrumentally assessed penetration aspiration scale scores. DSRS improved in both supratentorial and infratentorial stroke, with no difference between them (p = 0.32). In previously ventilated participants with tracheotomy, DSRS improved more in participants who could be decannulated (n = 66) -7.5 (-8.6, -6.5) versus not decannulated (n = 33) -2.1 (-3.2, -1.0) (p<0.001). 74 serious adverse events (SAE) occurred in 60 participants with pneumonia (9.2%) the most frequent SAE. Interpretation: In patients with neurogenic dysphagia, PES was safe and associated with reduced measures of dysphagia and penetration/aspiration. (C) 2020 The Author(s). Published by Elsevier Ltd.