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

Abstract

IntroductionTraumatic 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.MethodsThis 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.ResultsThe 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.DiscussionThe 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.ConclusionFurther research is needed to establish these findings’ generalizability and identify the optimal dosages and treatment protocols for rTMS and Cerebrolysin.

QEEG indices in traumatic brain injury - insights from the CAPTAIN RTMS trial

“…This may suggest that rTMS did not have any influence on the cerebral electrophysiological changes, while the CRB treatment was an important factor. Despite the previously reported correlation between increased DAR/DTABR and poorer functional and cognitive outcomes [ 40 , 41 , 44 , 45 ], our qEEG results correlated with improved, non-significant results at the neurocognitive tests for the CRB + TMS and CRB + sham groups [ 25 ].…”

“…The 180-day study visits and research therapy were conducted on an outpatient basis at the RoNeuro Institute for Neurological Research and Diagnostic in Cluj-Napoca, Romania. Detailed inclusion and exclusion criteria for patients are outlined in the main article [ 25 ]. Each participant's study schedule included three visits: Study Day 30 for screening and baseline, Study Day 101 for Visit 1, and Study Day 180 for Visit 2.…”

“…The primary objectives of this clinical trial were to determine if this combined therapy was feasible, effective, and safe compared to Cerebrolysin alone in improving various neurocognitive outcomes at three and six months post-TBI. Secondary objectives focused on assessing brain electrical activity using electroencephalography and analyzing eye movements with an eye-tracking (ET) device to test if QEEG and ET parameters may be considered possible biomarkers of cognitive dysfunction and neurorehabilitation [ 25 ].…”

The Rehabilitation Potential of Neurostimulation for Mild Traumatic Brain Injury in Animal and Human Studies

“…Another opportunity involves researching and optimizing stimulation parameters for those with mood disorders experiencing cognitive deficits due to mTBI and an adjacent study testing patients with moderate/severe TBI, e.g., [241][242][243][244][245]. Although the focus of this review was solely on cognition, hmTBI is highly comorbid with anxiety or depressive disorders, especially within the Veteran community [246].…”

Advancing clinical neuroscience in Romania: a decade of experience from the RoNeuro Institute for Neurological Research and Diagnostic

“…Using innovative neurophysiological tools and neurotrophic agents, the research activity at the RoNeuro Institute aims to improve functional outcomes and quality of life for patients affected by neurological disorders. In the field of TBI, we have investigated biological markers, pharmacological agents like Cerebrolysin, and non-pharmacological rehabilitation strategies such as repetitive transcranial magnetic stimulation (rTMS) [ 5 , 6 ]. Our studies have demonstrated the positive impact of these interventions on patient recovery, opening new avenues for treatment [ 5 , 6 ].…”