Effects of Methylphenidate on the Acute Management of Patients with Severe and Moderate Traumatic Brain Injury
- Conditions
- Moderate and Severe Traumatic Brain Injury.
- Registration Number
- IRCT2014010112776N3
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 200
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.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cognitive function. Timepoint: During 3 and 6 months of follow-up. Method of measurement: Using cognitive measuring tests.
- Secondary Outcome Measures
Name Time Method enght 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.