Purpose: Treatment of post-stroke dysphagia is notoriously difficult with different neurostimulation strategies having been employed with a variable degree of success. Recently, electrical pharyngeal stimulation (EPS) has been shown to improve swallowing function and in particular decrease airway aspiration in acute stroke. We performed a randomized controlled trial to assess EPS effectiveness on swallowing function in severely dysphagic tracheotomized patients.
Methods: All consecutive stroke patients successfully weaned from the respirator but with severe dysphagia precluding decannulation were screened for eligibility. Eligible patients were randomized to receive either EPS (N = 20) or sham stimulation (N = 10) over three consecutive days. Primary endpoint was ability to decannulate the patient. Swallowing function was assessed using fiberoptic endoscopy. Patients having received sham stimulation were offered EPS treatment during unblinded follow-up if required. Investigators were blinded to the patient's study group allocation.
Results: Both groups were well matched for age, stroke severity, and lesion location. Decannulation after study intervention was possible in 75% of patients of the treatment group and in 20% of patients of the sham group (p < 0.01). Secondary outcome parameters did not differ. No adverse events occurred.
Conclusion: In this pilot study, EPS enhanced remission of dysphagia as assessed with fiberoptic endoscopic evaluation of swallowing (FEES), thereby enabling decannulation in 75% of patients.
Trial registration: ClinicalTrials.gov NCT01956175.