Moderate and Severe Traumatic Brain Injury.
Conditions
Interventions
Intervention 1: Patients in the treatment(case) group will receive methylphenidate 20 mg/kg per dose PO BID by the second day of admission for two weeks. Intervention 2: Patients in the control group
Treatment - Drugs
Patients in the treatment(case) group will receive methylphenidate 20 mg/kg per dose PO BID by the second day of admission for two weeks.
Patients in the control group will receive placebo 20 mg/kg per dose PO BID by the second day of admission for two weeks.
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
16 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: ages between 16 and 60; having a history of non-penetrating traumatic brain injury with a GCS=6-8 (Severe) and GCS 9-12 (Moderate) without multi organ injury or failure. Exclusion criteria: not agreeing to enter the study; not being able to tolerate nasogastric Feeding; dying in 48 hours of admission; having a history of pre-morbid neurologic disease, psychosis, major affective disorder, developmental disability, ADHD, currently abusing alcohol or recreational drugs. taking psychoactive medications other than anticonvulsants. having systemic diseases that could have affected the results eg. Diabetes or psychiatric problems, pregnancy or likely to become pregnant; mental retardation, behavioral problems, impairments in vision, hearing, or motor function that were severe enough to preclude participation in the research tasks.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function. Timepoint: During 3 and 6 months of follow-up. Method of measurement: Using cognitive measuring tests. | — |
Secondary
| Measure | Time frame |
|---|---|
| Lenght of ICU stay. Timepoint: Total ICU treatment duration. Method of measurement: Based on patients' file and record.;Lenght of overall hospital stay. Timepoint: Total hospital treatment duration. Method of measurement: Based on patients' file and record.;GCS. Timepoint: During 3 and 6 months of follow-up. Method of measurement: GCS specific tests.;GOSE. Timepoint: During 3 and 6 months of follow-up. Method of measurement: GOSE specific tests.;Disability Rating Score. Timepoint: During 3 and 6 months of follow-up. Method of measurement: DRS specific tests. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHosseinali Khalili
Shiraz Neurosciences Research Center
Outcome results
None listed