Combined neuropsychological, neurophysiological and psychophysiological assessment of the effects of N-Pep-12 on neurorecovery in patients after traumatic brain injury
Neurorecovery in patients after traumatic brain injury
This study is a prospective, randomized, controlled, single-blind clinical study designed to evaluate the effects of N-Pep-12 dietary supplementation (MemoProve/Cebrium) on neurocognitive recovery in patients with traumatic brain injury (TBI). A total of 200 participants will be enrolled and randomly assigned in a 1:1 allocation ratio to one of two study arms using block randomization (4 blocks) according to ICH E9 principles. Participants in the intervention group (n = 100) will receive N-Pep-12 at a dose of 90 mg once daily, administered orally as a dietary supplement for 180 days. Participants in the control group (n = 100) will receive no dietary supplementation and will continue with standard clinical care only.
1. Patients with mild, moderate, or severe traumatic brain injury (TBI) confirmed following a neurological/neurosurgical medical consultation. 2. Patients in the post-acute stage of TBI, at least 30 days after the traumatic brain injury, with a stable clinical status. 3. Presence of residual cognitive and/or affective dysfunction, documented through neuropsychological evaluation (e.g., MoCA and/or HADS) and/or persistent subjective neurocognitive complaints. 4. Isolated traumatic brain injury (AIS score ≤ 2 in other body regions). 5. Pre-injury Karnofsky Performance Status = 100. 6. Age between 18 and 80 years. 7. Patient able to provide written informed consent for participation in the study. 8. Patient willing and able to comply with the protocol requirements throughout the study duration. 9. Women of childbearing potential must have a negative urine pregnancy test and agree to use adequate contraception. 10. The patient must have been able to speak, read, and write prior to the accident.
1. Polytrauma patients (AIS score > 2 in other body regions). 2. Patients with spinal cord injuries. 3. Major active psychiatric disorders (e.g., major depression, schizophrenia, bipolar disorder, including patients receiving chronic treatment for these conditions). 4. Advanced hepatic, renal, or pulmonary disease. 5. Terminal medical diagnoses compatible with a life expectancy < 1 year. 6. Major substance dependence, including alcohol (according to the investigator’s opinion). 7. Injury to the dominant writing hand, which could influence cognitive measurements or test results (according to the investigator’s opinion).