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Study · Randomized controlled trial · 2025

8 results

Speech Therapy Combined With Cerebrolysin in Enhancing Nonfluent Aphasia Recovery After Acute Ischemic Stroke: ESCAS Randomized Pilot Study.

Homberg V, Jianu DC, Stan A, Strilciuc Ș, Chelaru VF, Karliński M, Brainin M, Heiss WD, Muresanu DF, Enderby PM

Stroke17 Feb 2025Cited by 12 (Europe PMC)

PMID39957612 (opens in a new tab)PMCIDPMC11932442 (opens in a new tab)DOI10.1161/strokeaha.124.049834 (opens in a new tab)PepBankPUB-39957612
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Summary

BackgroundStroke-induced aphasia significantly impacts communication and quality of life. Despite the standard treatment being speech and language therapy, outcomes vary, highlighting the need for additional therapies. Cerebrolysin, a neuroprotective and neurotrophic agent, has shown potential in stroke management. This study addresses the notable gap in research about the combined use of Cerebrolysin and speech therapy, evaluating their synergistic potential in the treatment of aphasia.MethodsThe ESCAS trial (The Efficacy and Safety of Cerebrolysin in the Treatment of Aphasia After Acute Ischemic Stroke), a prospective, randomized-controlled, double-blinded study was conducted in 2 Romanian stroke centers. Participants included those with left middle cerebral artery territory ischemic stroke and nonfluent aphasia, enrolled 3 to 5 days poststroke. Inclusion criteria were right-handedness and Romanian as the mother tongue. Participants received Cerebrolysin or a placebo combined with speech and language therapy in 10-day cycles over 3 intervals, and evaluations were done at baseline, 30, 60, and 90 days respectively. The main outcome measure was Western Aphasia Battery for language function. Changes at days 30, 60, and 90 compared with baseline were quantified, and the effect estimand used was the difference in means between groups. Secondary outcome measurements were the National Institutes of Health Stroke Scale for neurological deficit, the modified Rankin Scale for global disability, and the Barthel Index for activities of daily living.ResultsOut of 132 enrolled patients, 123 were included in the intention-to-treat analysis, and 120 in the per-protocol analysis. Overall, both groups showed improvement at subsequent visits compared with the baseline for Western Aphasia Battery and the National Institutes of Health Stroke Scale. The Cerebrolysin group showed greater improvements in Western Aphasia Battery (visit 4 mean increase of 35.579±16.316 [95% CI, 31.289-39.869] points; PPP<0.001). The Cerebrolysin group also showed significant improvements (higher decreases) in National Institutes of Health Stroke Scale scores compared with the placebo group (2.085 [95% CI, 1.076-3.094] points; P<0.001). Safety analysis raised no concerns (number of patients with adverse events P=0.105, number of adverse events per patient P=0.134). Additionally, the Cerebrolysin group showed greater improvements in functional independence (Barthel Index) and a trend toward reduced disability (modified Rankin Scale) compared with the placebo group.ConclusionsCerebrolysin combined with speech and language therapy offers promising potential for enhancing recovery in poststroke nonfluent aphasia. Significant improvements were observed in language and neurological deficits, underscoring the importance of adjunctive therapies in nonfluent aphasia rehabilitation. Further research with larger cohorts is needed to fully establish the efficacy of this combination therapy.RegistrationURL: https://www.isrctn.com; Unique identifier: ISRCTN54581790.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with poststroke nonfluent aphasia, Cerebrolysin improved Western Aphasia Battery scores more than placebo.

    In plain wordsIn patients with poststroke aphasia, Cerebrolysin improved language scores more than placebo.

    Peptide
    Cerebrolysin
    Outcome
    IncreaseWestern Aphasia Battery improvement
    Study

    n: not reported in source

    Comparator
    Placebo with speech and language therapy
    Analysis
    Primary
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    Dose not stated · 10-day cycles over 3 intervalsAs given in this study (human).

    Measurements

    Difference in mean improvement
    14.805 points
    Cerebrolysin versus placebo
    Western Aphasia Battery mean increase
    35.579 points
    Cerebrolysin with speech and language therapy; visit 4 change from baseline
    Western Aphasia Battery mean increase ± term (type not stated)
    16.316 points
    Cerebrolysin with speech and language therapy; visit 4 change from baseline
    95% confidence interval for Western Aphasia Battery mean increase
    31.289 to 39.869 points
    Cerebrolysin with speech and language therapy; visit 4 change from baseline
    P value for Western Aphasia Battery change from baseline
    < 0.001
    Cerebrolysin with speech and language therapy; visit 4 change from baseline
    Western Aphasia Battery mean increase
    20.774 points
    placebo with speech and language therapy; visit 4 change from baseline
    Western Aphasia Battery mean increase ± term (type not stated)
    12.486 points
    placebo with speech and language therapy; visit 4 change from baseline
    95% confidence interval for Western Aphasia Battery mean increase
    17.603 to 23.945 points
    placebo with speech and language therapy; visit 4 change from baseline

    3 more measurements in the study.

    Source sentences

    Summary
    The Cerebrolysin group showed greater improvements in Western Aphasia Battery (visit 4 mean increase of 35.579±16.316 [95% CI, 31.289-39.869] points; PPP<0.001).
    2 context sentences
    Summary · context
    Participants included those with left middle cerebral artery territory ischemic stroke and nonfluent aphasia, enrolled 3 to 5 days poststroke.
    Summary · context
    Participants received Cerebrolysin or a placebo combined with speech and language therapy in 10-day cycles over 3 intervals, and evaluations were done at baseline, 30, 60, and 90 days respectively.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In poststroke aphasia patients, Western Aphasia Battery scores increased from baseline in both Cerebrolysin and placebo groups receiving speech therapy.

    In plain wordsIn poststroke aphasia patients, Western Aphasia Battery scores increased from baseline in both Cerebrolysin and placebo groups receiving speech therapy.

    Peptide
    Cerebrolysin
    Outcome
    IncreaseWestern Aphasia Battery change from baseline
    Study

    n: not reported in source

    Comparator
    Baseline in both treatment groups
    Analysis
    Primary
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    Dose not stated · 10-day cycles over 3 intervalsAs given in this study (human).

    Measurements

    Western Aphasia Battery mean increase
    35.579 points
    Cerebrolysin with speech and language therapy; visit 4 change from baseline
    Western Aphasia Battery mean increase ± term (type not stated)
    16.316 points
    Cerebrolysin with speech and language therapy; visit 4 change from baseline
    95% confidence interval for Western Aphasia Battery mean increase
    31.289 to 39.869 points
    Cerebrolysin with speech and language therapy; visit 4 change from baseline
    P value for Western Aphasia Battery change from baseline
    < 0.001
    Cerebrolysin with speech and language therapy; visit 4 change from baseline
    Western Aphasia Battery mean increase
    20.774 points
    placebo with speech and language therapy; visit 4 change from baseline
    Western Aphasia Battery mean increase ± term (type not stated)
    12.486 points
    placebo with speech and language therapy; visit 4 change from baseline
    95% confidence interval for Western Aphasia Battery mean increase
    17.603 to 23.945 points
    placebo with speech and language therapy; visit 4 change from baseline
    P value for Western Aphasia Battery change from baseline
    < 0.001
    placebo with speech and language therapy; visit 4 change from baseline

    Source sentences

    Summary
    Overall, both groups showed improvement at subsequent visits compared with the baseline for Western Aphasia Battery and the National Institutes of Health Stroke Scale.
    Summary
    The Cerebrolysin group showed greater improvements in Western Aphasia Battery (visit 4 mean increase of 35.579±16.316 [95% CI, 31.289-39.869] points; PPP<0.001).
    1 context sentence
    Summary · context
    Participants received Cerebrolysin or a placebo combined with speech and language therapy in 10-day cycles over 3 intervals, and evaluations were done at baseline, 30, 60, and 90 days respectively.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with poststroke nonfluent aphasia, Cerebrolysin reduced NIHSS scores more than placebo.

    In plain wordsIn patients with poststroke aphasia, Cerebrolysin reduced neurological deficit scores more than placebo.

    Peptide
    Cerebrolysin
    Outcome
    DecreaseNIHSS improvement
    Study

    n: not reported in source

    Comparator
    Placebo with speech and language therapy
    Analysis
    Secondary
    Outcome group
    Neuroprotection · Nervous system and cognition
    Studied dose
    Dose not stated · 10-day cycles over 3 intervalsAs given in this study (human).

    Measurements

    Difference in decreases
    2.085 points
    Cerebrolysin versus placebo
    95% confidence interval for difference in NIHSS decreases
    1.076 to 3.094 points
    Cerebrolysin versus placebo
    P value for NIHSS improvement between groups
    < 0.001
    Cerebrolysin versus placebo

    Source sentences

    Summary
    The Cerebrolysin group also showed significant improvements (higher decreases) in National Institutes of Health Stroke Scale scores compared with the placebo group (2.085 [95% CI, 1.076-3.094] points; P<0.001).
    2 context sentences
    Summary · context
    Participants included those with left middle cerebral artery territory ischemic stroke and nonfluent aphasia, enrolled 3 to 5 days poststroke.
    Summary · context
    Participants received Cerebrolysin or a placebo combined with speech and language therapy in 10-day cycles over 3 intervals, and evaluations were done at baseline, 30, 60, and 90 days respectively.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with poststroke aphasia, Cerebrolysin improved Barthel Index scores more than placebo.

    In plain wordsIn patients with poststroke aphasia, Cerebrolysin improved daily activity scores more than placebo.

    Peptide
    Cerebrolysin
    Outcome
    IncreaseBarthel Index improvement
    Study

    n: not reported in source

    Comparator
    Placebo with speech and language therapy
    Analysis
    Secondary
    Outcome group
    Exercise and physical function · Nervous system and cognition
    Studied dose
    Dose not stated · 10-day cycles over 3 intervalsAs given in this study (human).

    Source sentences

    Summary
    Additionally, the Cerebrolysin group showed greater improvements in functional independence (Barthel Index) and a trend toward reduced disability (modified Rankin Scale) compared with the placebo group.
    2 context sentences
    Summary · context
    Participants included those with left middle cerebral artery territory ischemic stroke and nonfluent aphasia, enrolled 3 to 5 days poststroke.
    Summary · context
    Participants received Cerebrolysin or a placebo combined with speech and language therapy in 10-day cycles over 3 intervals, and evaluations were done at baseline, 30, 60, and 90 days respectively.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with poststroke aphasia, Cerebrolysin showed a trend toward reduced disability compared with placebo.

    In plain wordsIn patients with poststroke aphasia, Cerebrolysin showed a trend toward less disability than placebo.

    Peptide
    Cerebrolysin
    Outcome
    DecreaseModified Rankin Scale disability
    Study

    n: not reported in source

    Comparator
    Placebo with speech and language therapy
    Analysis
    Secondary
    Outcome group
    Neuroprotection · Nervous system and cognition
    Studied dose
    Dose not stated · 10-day cycles over 3 intervalsAs given in this study (human).

    Source sentences

    Summary
    Additionally, the Cerebrolysin group showed greater improvements in functional independence (Barthel Index) and a trend toward reduced disability (modified Rankin Scale) compared with the placebo group.
    2 context sentences
    Summary · context
    Participants included those with left middle cerebral artery territory ischemic stroke and nonfluent aphasia, enrolled 3 to 5 days poststroke.
    Summary · context
    Participants received Cerebrolysin or a placebo combined with speech and language therapy in 10-day cycles over 3 intervals, and evaluations were done at baseline, 30, 60, and 90 days respectively.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In poststroke aphasia patients, NIHSS scores decreased from baseline in both Cerebrolysin and placebo groups receiving speech therapy.

    In plain wordsIn poststroke aphasia patients, NIHSS scores decreased from baseline in both Cerebrolysin and placebo groups receiving speech therapy.

    Peptide
    Cerebrolysin
    Outcome
    DecreaseNIHSS change from baseline
    Study

    n: not reported in source

    Comparator
    Baseline in both treatment groups
    Analysis
    Secondary
    Outcome group
    Neuroprotection · Nervous system and cognition
    Studied dose
    Dose not stated · 10-day cycles over 3 intervalsAs given in this study (human).

    Source sentences

    Summary
    Overall, both groups showed improvement at subsequent visits compared with the baseline for Western Aphasia Battery and the National Institutes of Health Stroke Scale.
    1 context sentence
    Summary · context
    Participants received Cerebrolysin or a placebo combined with speech and language therapy in 10-day cycles over 3 intervals, and evaluations were done at baseline, 30, 60, and 90 days respectively.
  7. 07HumanRandomized controlled trialSafety outcome

    In patients with poststroke aphasia, the number with adverse events did not differ significantly between Cerebrolysin and placebo.

    In plain wordsIn patients with poststroke aphasia, adverse event occurrence did not differ significantly between Cerebrolysin and placebo.

    Peptide
    Cerebrolysin
    Outcome
    No significant changePatients with adverse events
    Study

    n: not reported in source

    Comparator
    Placebo with speech and language therapy
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 10-day cycles over 3 intervalsAs given in this study (human).

    Measurements

    P value for number of patients with adverse events
    0.105
    Cerebrolysin versus placebo with speech and language therapy

    Source sentences

    Summary
    Safety analysis raised no concerns (number of patients with adverse events P=0.105, number of adverse events per patient P=0.134).
    2 context sentences
    Summary · context
    Participants included those with left middle cerebral artery territory ischemic stroke and nonfluent aphasia, enrolled 3 to 5 days poststroke.
    Summary · context
    Participants received Cerebrolysin or a placebo combined with speech and language therapy in 10-day cycles over 3 intervals, and evaluations were done at baseline, 30, 60, and 90 days respectively.
  8. 08HumanRandomized controlled trialSafety outcome

    In patients with poststroke aphasia, adverse events per patient did not differ significantly between Cerebrolysin and placebo.

    In plain wordsIn patients with poststroke aphasia, adverse events per patient did not differ significantly between Cerebrolysin and placebo.

    Peptide
    Cerebrolysin
    Outcome
    No significant changeAdverse events per patient
    Study

    n: not reported in source

    Comparator
    Placebo with speech and language therapy
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 10-day cycles over 3 intervalsAs given in this study (human).

    Measurements

    P value for number of adverse events per patient
    0.134
    Cerebrolysin versus placebo with speech and language therapy

    Source sentences

    Summary
    Safety analysis raised no concerns (number of patients with adverse events P=0.105, number of adverse events per patient P=0.134).
    2 context sentences
    Summary · context
    Participants included those with left middle cerebral artery territory ischemic stroke and nonfluent aphasia, enrolled 3 to 5 days poststroke.
    Summary · context
    Participants received Cerebrolysin or a placebo combined with speech and language therapy in 10-day cycles over 3 intervals, and evaluations were done at baseline, 30, 60, and 90 days respectively.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    14 Oct 2026, 05:02 UTC

    Study results updated

  2. Version 1

    14 Oct 2026, 01:46 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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