Traumatic brain injury (TBI) with Glasgow Coma Scale (GCS) scores between 7 and 12. Nervous System Diseases
Conditions
Interventions
The synopsis of the study is organised in 4 visits.
1. Screening and baseline
2. Day 10 evaluation
3. Day 30 evaluation
4. Day 90 evaluation
No follow-up was performed after the 90-day evaluation. Th
Sponsors
EN: The foundation for the study of neuroscience and reuroregeneration (RO: Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of TBI and a GCS score of 7-12 at the time of hospital admission. Pre-hospital intubation/sedation/paralysis is accepted if the GCS score has been assessed before intubation/sedation/paralyses by trained personnel. 2. Pre-treatment GCS score of 7-12. If intubation/sedation/paralysis occurs after hospital admission, the pre-treatment GCS score has been assessed before intubation/sedation/paralyses. 3. Isolated TBI only (abbreviated injury score (AIS) in other body regions of =2) 4. CT (Marshal classification) I to VI (from diffuse injury to non-evacuated mass lesion) 5. Pre-Trauma Karnofsky Index = 100. If no corresponding information is available before the start of treatment (e.g., patient is unconscious or not able to communicate) and no information is retrieved within 24 hours after the start of treatment, the patient stays in the study. If no information is available before the start of treatment and a violation of the Karnofsky Index is detected within 24 hours after the start of treatment, the patient is withdrawn from the study, and the treatment medication is stopped. 6. Aged 18-80 years 7. Able to provide written informed consent to enrollment 8. Willing and able to comply with the protocol requirements for the duration of the study 9. Women of child-bearing potential with a negative urine pregnancy test who are willing to practice an acceptable method of birth control 10. Time to needle for study medication should be within 4 hours 11. Patients were able to speak, read and write before the accident. If no corresponding information is available before the start of treatment (e.g., patient is unconscious or not able to communicate) and if no information is retrieved within 24 hours after the start of treatment, the patient should remain in the study. If no information is available before the start of treatment and if a violation of this inclusion criterion is detected within 24 hours after the start of treatment, the patient should be withdrawn from the study, and the treatment medication should be stopped.
Exclusion criteria
Exclusion criteria: 1. Patients with polytrauma (AIS score in other body regions of >2) 2. Patients with spinal cord injury 3. History of intracranial interventionor ischemic or hemorrhagic stroke 4. Existence of psychiatric disorders or neurodegenerative diseases 5. Patients who in the investigator’s opinion would not comply with study procedures 6. Patients with a history of epileptic seizure 7. Use of concomitant neuroprotective treatment or cholinesterase inhibitors for previous cognitive treatment 8. Persons who are under chronic treatment with cortisone, Ca+-channel blockers, antidepressants, antipsychotic drugs or nootropic molecules 9. Significant or unstable medical, systemic or logistical condition that affects the subject’s ability to give informed consent or to complete the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cognitive function assessed using PSI (Processing Speed Index, Wechsler adult intelligence scale – third edition) at days 10, 30, 90. 2. Cognitive function assessed using Stroop Color-Word Test – Victoria Version (VST) (Marcus, 1976) at days 10, 30, 90. 3. Cognitive function assessed using Color Trails Test (Posch, 2005) at days 30, 90. 4. Cognitive function assessed using Digit Span (Wechsler adult intelligence scale – third edition (Wechsler, 1997) at days 30, 90. 5. Cognitive function assessed using Early Rehabilitation Barthel Index (Schoenle, 1995) at days 10, 30, 90. 6. Cognitive function assessed using Finger Tapping Test (Huang, 2008) at days 30, 90. 7. Cognitive function assessed using Mini-Mental State Examination (MMSE) (Folstein, 1975) at days 10, 30, 90. 8. Emotional status assessed using Hospital Anxiety and Depression Scale (Zigmond, 1983) at days 30, 90. 9. Cognitive function assessed using Glasgow Outcome Scale Extended (GOS-E) (Wilson,1998) at days 10, 30, 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum biomarkers assessed using NSE, S-100 B and APOE e2-4 levels at baseline. | — |
Countries
Romania
Outcome results
None listed