Pharyngeal electrical stimulation to treat dysphagia in acute stroke: learnings from cases in the PhEED clinical trial.

Abstract

To assess the efficacy of pharyngeal electrical stimulation in improving dysphagia post-stroke. A randomized, sham-controlled, blinded multicentre clinical trial. Seventeen patients with acute ischaemic or haemorrhagic stroke experiencing dysphagia, indicated by a penetration aspiration scale score of 4-8 on videofluoroscopy. Sites enrolled 3 open-label roll-in participants and then randomized subsequent participants to either stimulation or sham treatment. Study interventions were delivered for 10 min daily over 3 consecutive days. Prior to data lock the primary outcome was modified to the change in dysphagia severity rating scale from pre-treatment to end of follow-up period. Secondary outcomes included penetration-aspiration scale score assessed via videofluoroscopy 48 h after final treatment and functional oral intake scale, measured at 7, 14, and 83 days post-randomization. The trial was halted early due to low recruitment, with 15 participants receiving active stimulation and 2 receiving sham treatment. Active stimulation significantly reduced dysphagia severity at day 83 (difference: -4, p = 0.027). Improvements were observed in diet and supervision subscales, and functional oral intake scores. Of those treated, 67% were discharged home, with no serious adverse events attributable to the intervention noted in either group. Pharyngeal electrical stimulation was safe and associated with reduced dysphagia severity in stroke patients, warranting further validation in larger studies.