ABSTRACT NUMBER: ESOC2026A1353 TABLET-ASSISTED SPEECH AND LANGUAGE THERAPY FOR ACUTE POST-STROKE APHASIA: A RANDOMIZED CLINICAL TRIAL (LEXI STUDY)

Abstract Background and aims Aphasia after acute stroke is a frequent and disabling condition, impairing communication and quality of life. We investigated whether tablet-assisted Speech and Language Therapy (SLT) using the Neolexon application is superior to standard SLT in acute stroke patients. Methods In this open-label, randomized, controlled clinical trial, patients with acute post-stroke aphasia were recruited from one stroke center and two neurorehabilitation clinics in Germany. Participants were stratified by aphasia severity and randomized to tablet-assisted SLT (n = 53) or standard SLT (n = 51), initiated during inpatient care and continued in rehabilitation (30 minutes/Day). The primary outcome was the change in the Bielefelder Aphasia Screening (BIAS) percentile rank from baseline to 90 days. Secondary outcomes included frequency and duration of self-training. Results From 07/2021 to September 4, 2024,097 patients were screened and 104 randomized (mean age 74.4 ± 11.2 years; 51.9% female). No significant difference in BIAS change was found at 90 days (18 vs. 14). The trial was stopped early for futility. The intervention group engaged in self-directed training more frequently (37.7% vs. 21.6%) and trained longer (10 vs. 4 hours). Subgroup analyses showed benefits of tablet-assisted SLT in patients with mild (β = 15.51; 95% CI -1.67 to 32.69) and moderate aphasia (β = 23.58; 95% CI -4.48 to 51.65), and those with a NIHSS of less than 5 (β = 21.69; 95% CI 5.54-37.84). Conclusions Although underpowered to demonstrate overall superiority, tablet-assisted SLT showed potential benefits in patients with mild to moderate aphasia and less severe strokes in the acute setting. Conflict of interest K.L. was employed as a project lead at Limedix GmbH during part of the study period. Limedix is the manufacturer of the Neolexon application evaluated in this study. This relationship had no influence on the study design, data collection, data analysis, or interpretation of the results. P.Y. received funding for travel or speaker honoraria from Idorsia, Sanofi, Amicus, Löwenstein Medical, Bioprojet and Mementor outside of this study. P.Y. is supported by the Dr. Werner und Raphael Müller Narcolepsy Foundation. K.F. received grants from the University of Tübingen (AKF and Sigrid-Örgel Stiftung) and speakers’ honoraria/consulting fees from AstraZeneca and BMS/Pfizer, all not related to this work. L.K. received funding for travel or speaker honoraria from Alexion, AstraZeneca, Bayer Vital, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Lilly and Pfizer outside of this study.