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

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. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial https://www.isrctn.com/ISRCTN54581790 ### Clinical Protocols ### Funding Statement This study was from the own resources of the academic sponsors, the Society for the Study of Neuroprotection and Neuroplasticity (SSNN) and Foundation for the Study of Nanoneuroscience and Neuroregeneration (FSNANO). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the Ethics Committee of the Iuliu Hatieganu University of Medicine and Pharmacy (8 Babe? Street, 400012 Cluj-Napoca, Romania; internal reference number: 122/24.03.2020) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data on which analyses have been performed is available as supplementary material. Further data requests may be made to the corresponding authors.