100 Severe and 100 Moderate consecutive traumatic brain injured patients admitted to Rajaee hospital (Shiraz, Iran) in the acute phase of recovery will be recruited into a randomized, double blind, placebo controlled trial.
The patients will be divided into two groups of: severely brain injured and moderately brain injured patients. After which form each of the two groups a control group will be randomly selected.
Methylphenidate and a placebodrug will be administered over a 2 week period for each of the groups. The treatment(case) group will receive methylphenidate 20 mg/kg per dose PO BID by the second day of admission until 2 weeks. Admission demographic information and also initial clinical evaluation results including: vital signs, injury severity score, CT findings, intracranial pressure monitoring (if performed), and daily Glasgow Coma Scale (GCS), will be recorded.
Information regarding ICU and Hospital Stay, GCS, GOSE and DRS (disability rating score) on discharge and after 3 and 6 months will be recorded prospectively and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010112776N3
Registration date:2014-12-28, 1393/10/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-28, 1393/10/07
Registrant information
Name
Hosseinali Khalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3625 4206
Email address
khalili_h@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research affairs of Shiraz University of Medical Sciences and Health Services
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Methylphenidate on the Acute Management of Patients with Severe and Moderate Traumatic Brain Injury
Public title
Effects of Methylphenidate on the Acute Management of Patients with Severe and Moderate Traumatic Brain Injury
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Vice-chancellor for Research affairs, at 7th floor, Shiraz University of Medical Sciences, Zand Avenue, Shiraz, Iran
City
Shiraz
Postal code
7194815644
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
CT-P-92-5276
Health conditions studied
1
Description of health condition studied
Moderate and Severe Traumatic Brain Injury
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cognitive function
Timepoint
During 3 and 6 months of follow-up
Method of measurement
Using cognitive measuring tests
Secondary outcomes
1
Description
Lenght of ICU stay
Timepoint
Total ICU treatment duration
Method of measurement
Based on patients' file and record
2
Description
Lenght of overall hospital stay
Timepoint
Total hospital treatment duration
Method of measurement
Based on patients' file and record
3
Description
GCS
Timepoint
During 3 and 6 months of follow-up
Method of measurement
GCS specific tests
4
Description
GOSE
Timepoint
During 3 and 6 months of follow-up
Method of measurement
GOSE specific tests
5
Description
Disability Rating Score
Timepoint
During 3 and 6 months of follow-up
Method of measurement
DRS specific tests
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Patients in the control group will receive placebo 20 mg/kg per dose PO BID by the second day of admission for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaee Hospital
Full name of responsible person
Hossein Ali Khalili
Street address
Shiraz Neurosciences Research Center-Chamran Hospital-Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Research affairs, Shiraz University of medical Sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz Neurosciences Research Center
Full name of responsible person
Hosseinali Khalili
Position
Neurosurgeon
Other areas of specialty/work
Street address
Chamran hospital N/S Dept
City
Shiraz
Postal code
Phone
+98 71 1623 4508
Fax
Email
khalilih16@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Neurosciences Research Center
Full name of responsible person
Hosseinali Khalili
Position
Neurosurgeon
Other areas of specialty/work
Street address
Chamran hospital N/S Dept.
City
Shiraz
Postal code
Phone
+98 71 1623 4508
Fax
Email
khalilih16@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Neurosciences Research Center
Full name of responsible person
Hosseinali Khalili
Position
Assistant Professor
Other areas of specialty/work
Street address
Chamran hospital N/S Dept.
City
Shiraz
Postal code
Phone
+98 71 1623 4508
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)