The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate Traumatic Brain Injury (TBI) Patients (DCS)
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|ClinicalTrials.gov Identifier: NCT01343862|
Recruitment Status : Unknown
Verified April 2011 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : April 28, 2011
Last Update Posted : April 28, 2011
In this study of patients with moderate traumatic brain injury with frontal brain contusions patients will be randomized to treatment with a single dose of either D-cycloserine or placebo given 48-72 hours after injury.
Patients will undergo intensive neurocognitive testing at 3 and 6 months after injury to assess whether treatment with a single dose of D-cycloserine improves cognitive outcome after moderate brain injury.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Drug: D-cycloserine Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate TBI Patients|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||May 2014|
|Experimental: D- Cycloserine||
single dose of D-cycloserine given 48-72 hours after moderate traumatic brain injury
Other Name: seromycin
|Placebo Comparator: sugar pill||
A sugar pill will be given to those patients randomized to the control group at 48-72 hours after moderate brain injury
- A battery of neuropsychological tests at 3 and 6 months post-injury [ Time Frame: 3 and 6 months post-injury ]
- Symbol Digit Modalities Test (Smith 1973)
- Trail Making Test (TMT) (Reitan, Hom et al. 1988)
- Digit Span (DS) from the WAIS-III
- Rey Auditory Verbal Learning Test (RAVLT) (Rey 1955; Lezak 2004)
- Wisconsin Card Sorting Test (WCST) (Psychological Assessment Resources. Computerised Wisconsin Card Sort Task Version 4 (WCST). Psychological Assessment Resources; 2003).
- Test of Variables of Attention (TOVA) (Test of Variables of Attention: Clinical Manual. Los Alamitos: The TOVA Company).
- Behavioral Assessment of the Dysexecutive Syndrome (BADS) (Erez, Rothschild et al. 2009)
- Glasgow Outcome Score - Extended (GOS-E) [ Time Frame: 3 and 6 months post injury ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343862
|Contact: Guy Rosenthal, MDfirstname.lastname@example.org|
|Rambam Medical Center||Not yet recruiting|
|Contact: Leon Levi, MD email@example.com|
|Principal Investigator: Leon Levi, MD|
|Hadassah Medical Center||Not yet recruiting|
|Jerusalem, Israel, 91120|
|Principal Investigator: Guy Rosenthal, MD|
|Sheba Medical Center||Not yet recruiting|
|Ramat Gan, Israel|
|Contact: Nachshon Knoller, MD Knoller@sheba.health.gov.il|
|Principal Investigator: Nachshon Knoller, MD|
|Principal Investigator:||Guy Rosenthal, MD||Hadassah Medical Center|