Pharyngeal electrical stimulation to treat dysphagia in acute stroke: learnings from cases in the PhEED clinical trial.
Richard L Harvey, Richard Smith, Rajaram Bathula and 8 others
PMID 40908833WHAT IT FOUND
The trial stopped early with only 17 patients, so it cannot compare treatment to sham.
In the 15 who received pharyngeal electrical stimulation, swallowing severity improved, but the study cannot rule out natural recovery after stroke.
Key findings
01The trial was stopped early due to low recruitment, resulting in a case series rather than a valid randomized comparison.
02In the 15 patients treated with pharyngeal electrical stimulation, the Dysphagia Severity Rating Scale improved significantly from a median of 6 to 2 over 83 days.
03Instrumental measures of swallowing safety (Penetration-Aspiration Scale) did not show statistically significant improvement after treatment.
STILL TO COME
How it was doneWhat they foundWhat it means for SLPs
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What it does not show
The study was severely underpowered and stopped early, leaving only 17 participants. The comparison between treatment and sham was not possible due to the small number of randomized patients (1 active, 2 sham). The analysis is a case series, meaning it cannot distinguish the effect of the treatment from the natural recovery of swallowing function that occurs in the weeks after a stroke. The primary outcome was changed after recruitment began, which increases the risk of bias. Many eligible patients were excluded because their swallowing issues were milder than expected, suggesting the results may not apply to patients with severe dysphagia.
Declared interests
The study was funded and sponsored by Phagenesis Ltd, the manufacturer of the device. The sponsor was involved in the design, conduct, data management, and approval of the manuscript.
The easy way to misread this
Do not interpret the improvement in swallowing scores as proof that pharyngeal electrical stimulation works. The study lacked a valid control group due to early termination, so the results may simply reflect natural recovery after stroke.
Summarised by AI from the full paper, without a clinician reviewing it. Check it against the source before it changes what you do. Read it on PubMed →