Mild Traumatic Brain Injury, Moderate Traumatic Brain Injury (TBI)
Conditions
Keywords
Traumatic Brain Injury (TBI), Memantine, S100β
Brief summary
Memantine has shown promise in mitigating secondary brain injury in previous studies. One study demonstrated that early memantine administration in moderate TBI patients resulted in lower serum neuron-specific enolase levels and improved Glasgow Coma Scale scores. However, other trials investigating memantine's impact on long-term cognitive function in TBI patients have yielded mixed results. There is a need for well-controlled studies to determine the efficacy of memantine in improving neurological and cognitive outcomes in patients with TBI.
Detailed description
The current study aims to evaluate the cognitive function, neuroprotective effect, and S-100β serum level effect of Memantine in patients with mild to moderate traumatic brain injury (TBI) patients.
Interventions
DRUGMemantine
Memantine will be given either orally or through a nasogastric tube for 7 days, starting on the first day of admission to the hospital and then continued for 3 weeks. The memantine dose in the first 7 days is 30 mg twice daily, while during the remaining 3 weeks the dose is 10 mg twice daily
DRUGMannitol
Mild to moderate TBI patients will receive mannitol in case of brain edema to reduce brain swelling and analgesic for headache such as; acetaminophen.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients between 18 and 70 years of age 2. Patients mild (GCS 13-15) to moderate (GCS 9-12) TBI were assessed for the study eligibility.
Exclusion criteria
1. Comorbid illnesses, such as diabetes mellitus, ischemic heart disease, acute myocardial infarction within the past 48 hours. 2. Acute or chronic renal insufficiency. 3. Hepatic diseases. 4. Autoimmune diseases. 5. Malignancies. 6. Pregnancy. 7. Patients unable to tolerate enteral feeding. 8. More than 24 hours (h) since traumatic injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference between the 2 groups regarding mean Montreal Cognitive Assessment (MOCA) scores at the end of treatment | 30 days | Score rage: 0 - 30. Normal cognition: 26 - 30, mild cognitive impairment: 18 - 25, moderate cognitive impairment: 10 - 17 and severe cognitive impairment: less than 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The differences between study groups in Glasgow Coma Scale (GCS) score. | 3 days | The differences between study groups in GCS scores over 3 days. The score ranges from 3 (Minimum score = deep coma or death) to 15 (Maximum score = fully awake and oriented). Traumatic brain injury (TBI) is graded as mild, moderate, or severe on the basis of the level of consciousness or Glasgow coma scale (GCS) score after resuscitation. Mild TBI score ranges from 13 to 15, moderate TBI ranges from 9 to 13; while severe TBI ranges from 3 to 8. |
| The difference between the two study groups in mean serum level of S100 calcium-binding protein B (S100B) | 3 days | The difference between the two study groups in mean serum level of S100 calcium-binding protein B (S100B) . |
Countries
Egypt
Outcome results
None listed