Abstract TMP46: Fostering Eating After Stroke (FEAST) Trial: A Randomized Controlled Trial of Non-Invasive Brain Stimulation for Improving Dysphagia After Stroke

Abstract

Background: Effective therapy for dysphagia recovery after stroke is currently lacking. We conducted a phase-2 RCT to investigate the effects of anodal transcranial direct current stimulation (atDCS) in reducing aspiration risk, improving diet, and analyzed its safety in the acute-subacute stroke phase. Hypothesis: Since swallowing has bi-hemispheric representation targeted atDCS to the unaffected hemisphere combined with swallowing exercises may improve dysphagia from a unilateral hemispheric infarction [UHI]. Methods: This phase-2, double-blind, RCT enrolled subjects with dysphagia [penetration and aspiration (PAS) score ≥ 4], from an acute-subacute UHI [day 2-day 6 after stroke onset] and randomized them into 3 groups: low-dose atDCS [2 mA atDCS alternating with sham twice daily], high-dose atDCS [2 mA atDCS twice daily] or sham [twice daily]. All sessions were performed with standardized swallowing exercises for 20 minutes over 5 days. Major safety outcomes were incidence of seizures, worsening of neurological and swallowing functions and mortality; primary efficacy outcome was a change in PAS scores between day 1 and 5 of intervention; main dietary outcome was a change in dietary intake at 1 month using the Functional Oral Intake scale (FOIS). Results: Of the planned 99 subjects, 42 could be enrolled in the funding period. No group differences in pre-defined safety outcomes were observed. Mean (SD) change in PAS score from baseline to final session was -0.8 (±1.6) in sham, -0.8 (±1.5) in low-dose and -0.4 (±1.2) in high dose groups. Adjusting for baseline PAS, NIHSS scores and age, means (SE) were -0.96 (0.33) in sham, -0.81 (0.36) in low-dose and -0.34 (0.35) in high dose; there were no significant pairwise differences (p>0.40). Mean (SD) changes in FOIS scores from baseline to 1 month were: 2.1 (±1.7) in sham, 2.5 (±1.7) in low-dose and 2.9 (±1.2) in high dose. Adjusted means (SE) were 2.07 (0.35) in sham, 2.46 (0.38) in low dose and 3.05 (0.38) in high dose (pairwise p > 0.15). Conclusion: Application of atDCS to the unaffected hemisphere is safe in the acute-subacute stroke phase but did not decrease aspiration risk in this phase-2 RCT. Higher doses of atDCS were associated with better dietary scores but group differences were not statistically significant.