Effects of N-Pep-12 on neurorecovery in patients after traumatic brain injury

Combined neuropsychological, neurophysiological and psychophysiological assessment of the effects of N-Pep-12 on neurorecovery in patients after traumatic brain injury

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16793972

Enrollment

200

Registered

2026-03-30

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurorecovery in patients after traumatic brain injury Injury, Occupational Diseases, Poisoning

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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).

Countries

Romania

Contacts

Public ContactNicoleta;Diana Jemna;Chira

;

nicoleta.jemna@brainscience.ro;diana.chira@brainscience.ro+40 756 027 452;-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026