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ESCAS Cerebrolysin

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

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Year of Publication: 2025

Authors: Volker Homberg, Dragoș Cătălin Jianu, Adina Stan, ..., Pamela M. Enderby

Journal: Stroke

Citation: Stroke. 2025;56:937–947. DOI: 10.1161/STROKEAHA.124.049834

Link: https://www.ahajournals.org/doi/10.1161/STROKEAHA.124.049834

PDF: https://www.ahajournals.org/doi/reader/1...EAHA.124.049834

Clinical Question

Does combining Cerebrolysin with structured speech and language therapy enhance recovery from nonfluent aphasia after acute ischemic stroke?

Bottom Line

Cerebrolysin combined with speech therapy led to significantly greater language and functional recovery than speech therapy alone in post-stroke nonfluent aphasia, with no additional safety concerns.

        Major Points
        132 patients with nonfluent aphasia after left MCA stroke randomized to Cerebrolysin or placebo, both with SLT
Primary outcome: WAB-AQ score improved significantly more with Cerebrolysin at all time points
Secondary outcomes (NIHSS, BI, mRS) also favored the Cerebrolysin group
No increase in adverse events in the Cerebrolysin group
Study powered for medium effect size and used ITT and PP analysis

      

Design

Study Type: Randomized, placebo-controlled, double-blind trial

Randomization: 1

Blinding: Patients, investigators, and study personnel blinded; colored infusion lines used to mask amber color of Cerebrolysin

Enrollment Period: June 2020 – October 2022

Follow-up Duration: 90 days

Centers: 2

Countries: Romania

Sample Size: 132

Analysis: Intention-to-treat and per-protocol; Wilcoxon tests, resampling-based MANOVA, Cohen d, Bonferroni correction; R and Excel used

Inclusion Criteria

Acute ischemic stroke in left MCA territory
Nonfluent aphasia
Enrollment 3–5 days poststroke
Right-handed
Romanian as primary language

Exclusion Criteria

Prior stroke
Global or fluent aphasia
History of epilepsy
Severe liver/renal failure
Life-threatening disease
Neurodegenerative or psychiatric disorders
Uncorrectable sensory deficits

Baseline Characteristics

Age (years): 70.5 ± 11.2 (Cerebrolysin), 67.7 ± 11.0 (Placebo)

Sex - Male: 56.1% (Cerebrolysin), 53% (Placebo)

WAB-AQ: 50.8 ± 19.8 (Cerebrolysin), 56 ± 22.4 (Placebo)

NIHSS: 9.2 ± 4.5 (Cerebrolysin), 8.6 ± 4.4 (Placebo)

Arms

Field	Cerebrolysin + SLT	Control
Intervention	30 mL IV Cerebrolysin in 250 mL saline daily for 10 days x 3 cycles + standardized speech therapy (30 hours total)	250 mL IV saline daily for 10 days x 3 cycles + standardized speech therapy (30 hours total)
Duration	90 days (3 treatment intervals over days 1–70)	90 days (3 treatment intervals over days 1–70)

Outcomes

Outcome	Type	Control	Intervention	P-value
Change in WAB-AQ (Western Aphasia Battery - Aphasia Quotient) from baseline to days 30, 60, and 90	Primary	+20.8 ± 12.5 at Day 90	+35.6 ± 16.3 at Day 90	<0.001
NIHSS (neurological deficit)	Secondary	−3.98 ± 2.16 at Day 90	−6.07 ± 3.26 at Day 90	<0.001
Barthel Index (ADLs)	Secondary	74.0 ± 24.2 at Day 90	82.6 ± 19.1 at Day 90	0.004
Modified Rankin Scale (disability)	Secondary	2.26 ± 1.28 at Day 90	1.76 ± 1.05 at Day 90	0.081
Any adverse event	Adverse	30.3%	43.9%	0.105
Serious adverse event	Adverse	Not statistically different	Not statistically different	0.381

Subgroup Analysis

All effects were consistent in intention-to-treat and per-protocol analyses; MANOVA confirmed time-dependent interaction effects favoring Cerebrolysin on WAB, NIHSS, and mRS.

Criticisms

Small sample size limits generalizability
Lack of control for lesion volume and stroke severity
Some therapy sessions conducted remotely due to pandemic
Short follow-up duration (90 days)

Funding

Funded academically by the Foundation of the Society for the Study of Neuroprotection and Neuroplasticity (SSNN) and FSNANO

Based on: ESCAS Cerebrolysin (Stroke, 2025)