Cerebrolysin and repetitive transcranial magnetic stimulation (rTMS) in patients with traumatic brain injury: a three-arm randomized trial.

Introduction: Traumatic brain injury (TBI) is a major public health problem affecting millions worldwide. Despite significant advances in medical care, there are limited effective interventions for improving cognitive and functional outcomes in TBI patients. Methods: This randomized controlled trial investigated the safety and efficacy of combining repetitive transcranial magnetic stimulation (rTMS) and Cerebrolysin in improving cognitive and functional outcomes in TBI patients. Ninety-three patients with TBI were randomized to receive either Cerebrolysin and rTMS (CRB + rTMS), Cerebrolysin and sham stimulation (CRB + SHM), or placebo and sham stimulation (PLC + SHM). The primary outcome measures were the composite cognitive outcome scores at 3 and 6 months after TBI. Safety and tolerability were also assessed. Results: The study results demonstrated that the combined intervention of rTMS and Cerebrolysin was safe and well-tolerated by patients with TBI. Although no statistically significant differences were observed in the primary outcome measures, the descriptive trends in the study support existing literature on the efficacy and safety of rTMS and Cerebrolysin. Discussion: The findings of this study suggest that rTMS and Cerebrolysin may be effective interventions for improving cognitive and functional outcomes in TBI patients. However, limitations of the study, such as the small sample size and exclusion of specific patient populations, should be considered when interpreting the results. This study provides preliminary evidence for the safety and potential efficacy of combining rTMS and Cerebrolysin in improving cognitive and functional outcomes in TBI patients. The study highlights the importance of multidisciplinary approaches in TBI rehabilitation and the potential for combining neuropsychological measurements and interventions to optimize patient outcomes. Conclusion: Further research is needed to establish these findings' generalizability and identify the optimal dosages and treatment protocols for rTMS and Cerebrolysin.

Evaluation of post-traumatic stress disorder (PTSD) and related comorbidities in clinical studies.

Patients with traumatic brain injury (TBI) of varying severities are experiencing adverse outcomes during and after rehabilitation. Besides depression and anxiety, post-traumatic stress disorder (PTSD) is highly encountered in civilian and military populations. As more prospective and retrospective studies - focused on evaluating new or old psychological therapies in inpatient, outpatient, or controlled environments, targeting patients with PTSD with or without a history of TBI - are carried out, researchers are employing various scales to measure PTSD as well as other psychiatric diagnoses or cognitive impairments that might appear following TBI. We aimed to explore the literature published between January 2010 and October 2021 by querying three databases. Our preliminary results showed that several scales - such as the Clinician-Administered PTSD Scale (CAPS), the Posttraumatic Stress Disorder Checklist Military Version (PCL-M) as well as Specific Version (PCL-S), and Civilian Version (PCL-C) - have been frequently used for PTSD diagnosis and symptom severity. However, heterogeneity in the scales used when assessing and evaluating additional psychiatric comorbidities and cognitive impairments are due to the study aim and therapeutic approaches. Therefore, conducting an intervention focusing on post-TBI PTSD patients requires increased attention to patients' medical history in capturing multiple cognitive impairments and affected neuropsychological processes when designing the study and including validated instruments for measuring primary and secondary neuropsychological outcomes.

The Effect of Cerebrolysin on Anxiety, Depression, and Cognition in Moderate and Severe Traumatic Brain Injury Patients: A CAPTAIN II Retrospective Trial Analysis.

Background and Objectives: Traumatic brain injuries represent an important source of disease burden requiring emergency inpatient care and continuous outpatient tailored rehabilitation. Although most TBIs are mild, patients are still developing post-TBI depression, anxiety, and cognitive impairments. Our secondary retrospective trial analysis aimed to (1) analyze correlations between HADS-Anxiety/HADS-Depression and scales that measure cognitive and motor processes in patients treated with Cerebrolysin compared to the placebo group and (2) compare anxiety and depression scores among the two treatment groups. Materials and Methods: Our secondary retrospective analysis focused on TBI patients with moderate and severe disability divided into two groups: Cerebrolysin (treatment) and saline solution (procedural placebo). We analyzed data from 125 patients. We computed descriptive statistics for nominal and continuous variables. We used Spearman's correlation to find associations between HADS and other neuropsychological scales and the Mann-Whitney U test to compare HADS-Anxiety and HADS-Depression scores among the two study arms. Results: Our sample consisted of patients with a mean age of 45.3, primarily men, and with a 24 h GCS (Glasgow Coma Scale) mean of 12.67. We obtained statistically significant differences for HADS-Anxiety during the second and third visits for patients treated with Cerebrolysin. Our results show that Cerebrolysin has a large effect size (0.73) on anxiety levels. In addition, there are positive and negative correlations between HADS-Anxiety and Depression subscales and other neuropsychological scales. Conclusions: Our secondary database analysis supports the existing body of evidence on the positive effect of Cerebrolysin on post-TBI mental health status. Future confirmatory trials are necessary to clarify the link between the intervention and measured outcomes.