Speech therapy combined with Cerebrolysin in enhancing aphasia recovery after acute ischemic stroke: ESCAS pilot study

Abstract Background Stroke-induced aphasia significantly impacts communication and quality of life. Despite the standard treatment being speech and language therapy (SLT), outcomes vary, highlighting the need for additional therapies. Cerebrolysin, a neuroprotective and neurotrophic agent, has shown potential in stroke management. This study examines the effectiveness of combining Cerebrolysin with SLT in treating post-stroke aphasia. Methods The ESCAS trial, a prospective, randomized-controlled, double-blinded phase 4 study, was conducted in two Romanian stroke centers. Participants included those with left middle cerebral artery territory ischemic stroke and Broca or mixed non-fluent aphasia, enrolled 3-5 days post-stroke. Inclusion criteria were right-handedness and Romanian as mother tongue; exclusion criteria were prior strokes, severe comprehension deficits, contraindications to MRI, and pre-existing neurodegenerative or psychiatric diseases. Participants received Cerebrolysin or a placebo combined with SLT in ten-day cycles over three intervals. Results Out of 132 enrolled patients, 123 were included in the Intention To Treat analysis, and 120 in the Per Protocol analysis. The Cerebrolysin group showed significant improvement in Western Aphasia Battery scores (p < 0.001) and National Institutes of Health Stroke Scale scores (p < 0.001). Modified Rankin Scale and Barthel index scores also improved, with notable differences at the final study visit (Day 90). Safety analysis raised no concerns. Conclusions Cerebrolysin combined with SLT offers promising potential for enhancing recovery in post-stroke aphasia. Significant improvements were observed in language and neurological deficits, underscoring the importance of adjunctive therapies in aphasia rehabilitation. Further research with larger cohorts is needed to fully establish the efficacy of this combination therapy. Clinical Trial Registration https://www.isrctn.com/ISRCTN54581790