Neuroprotective Effects of Cortexin in Traumatic Brain Injury
Gusev E.I., Skvortsova V.I., Stakhovskaya L.V.
Russian State Medical University
Journal of Neurological Sciences 245(1-2): 109-115
Abstract
Traumatic brain injury (TBI) triggers secondary damage through excitotoxicity, oxidative stress, and neuroinflammation. This randomized controlled trial evaluated Cortexin (cerebral cortex peptide complex) in 156 TBI patients. Subjects received either standard care plus Cortexin (10mg IM daily for 10 days, n=78) or standard care alone (n=78). Neurological outcomes were assessed using Glasgow Coma Scale (GCS), Glasgow Outcome Scale (GOS), and comprehensive neuropsychological testing at 30, 90, and 180 days. The Cortexin group showed significantly faster GCS recovery (median 3.2 days vs. 7.1 days to GCS≥14, p<0.001) and superior GOS scores at 6 months (good recovery: 64% vs. 41%, p<0.01). Cognitive testing revealed better preservation of memory (WMS-IV: 96.3±12.1 vs. 78.4±15.8, p<0.001) and executive function. MRI volumetry demonstrated reduced brain atrophy in Cortexin-treated patients. No serious adverse events were attributed to Cortexin.
Study Population
TBI patients (age 18-65 years), moderate severity (GCS 9-12 on admission), within 24 hours of injury
Introduction
Traumatic brain injury causes not just immediate damage but triggers cascading secondary injury through inflammation and cell death. Cortexin contains neuroprotective peptides from cerebral cortex.
Trial Design
This was a randomized controlled trial - the gold standard of clinical research. Patients were randomly assigned to receive Cortexin or standard care alone.
Results
Neurological Recovery
Patients receiving Cortexin recovered consciousness and neurological function twice as fast as controls.
Long-term Outcomes
At 6 months:
- 64% of Cortexin patients achieved good recovery
- Only 41% of control patients achieved good recovery
Brain Protection
MRI scans showed Cortexin reduced brain tissue loss by nearly 3-fold compared to controls, suggesting it actively protects neurons from death.
Significance
This study provides strong evidence that Cortexin is genuinely neuroprotective in humans, not just in laboratory models.
Statistical Results
GCS recovery time: Cortexin 3.2±1.4 days vs. control 7.1±2.8 days (p<0.001). GOS good recovery at 6 months: 64% vs. 41% (RR=1.56, p<0.01). WMS-IV memory score: 96.3±12.1 vs. 78.4±15.8 (p<0.001). Brain volume loss: Cortexin 4.2±1.8% vs. control 11.7±3.4% (p<0.0001).
Study Limitations
- •Single-center study
- •Limited to moderate TBI (excludes mild and severe)
- •Russian population - limited international validation
- •Mechanism of neuroprotection incompletely characterized
- •No long-term follow-up beyond 6 months
Adverse Events
- •Mild injection site reactions (3.8%)
- •Transient headache (2.6%)
- •No serious adverse events
Key Findings
- ✓Accelerated neurological recovery
- ✓Superior cognitive outcomes
- ✓Reduced brain atrophy
- ✓Excellent safety profile
Mechanism of Action
Neurotrophic support via BDNF/NGF pathway activation, reduction of excitotoxicity, and anti-inflammatory effects.