Sobral

Researchers are investigating the use of biperiden to prevent post traumatic epilepsy (PTE), a common neurological complication following moderate to severe traumatic brain injury (TBI). PTE accounts for 5% of all epilepsy cases and often develops within two years after injury. Currently, no effective treatment exists to reduce the risk of PTE. Previous animal studies suggest biperiden may lower both the occurrence and severity of epileptic seizures and delay their onset, making it a promising candidate for preventing PTE. Participants will be randomly assigned to receive either 5 mg of biperiden diluted in saline or a placebo infusion every 6 hours for 10 consecutive days starting within 18 hours after their brain injury. The treatment is given intravenously. The study will follow patients for two years, with periodic visits to monitor the development of epileptic seizures and assess other factors such as brain activity abnormalities, genetic markers, and cognitive function. The study also aims to evaluate any side effects of biperiden at these doses and its cost-effectiveness in the healthcare system. Throughout the study, patients will undergo brain scans, clinical evaluations, and neuropsychological assessments. Researchers will track the incidence of PTE and record any severe adverse events over 24 months. Monitoring will include evaluating treatment safety and effectiveness, alongside measuring quality of life and other health outcomes. The total participation time for each patient is two years, allowing for comprehensive observation of long-term effects and epilepsy prevention.