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DCS: The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate Traumatic Brain Injury (TBI) Patients

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Unknown status
CT.gov ID
NCT01343862
Collaborator
(none)
100
Enrollment
3
Locations
2
Arms
33
Duration (Months)
33.3
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate TBI Patients
Study Start Date :
Aug 1, 2011
Anticipated Primary Completion Date :
May 1, 2014
Anticipated Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: D- Cycloserine

Drug: D-cycloserine
single dose of D-cycloserine given 48-72 hours after moderate traumatic brain injury
Other Names:
  • seromycin

    		•
    Placebo Comparator: sugar pill

    Drug: placebo
    A sugar pill will be given to those patients randomized to the control group at 48-72 hours after moderate brain injury

    Outcome Measures

    Primary Outcome Measures

    1. A battery of neuropsychological tests at 3 and 6 months post-injury [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)

    Secondary Outcome Measures

    1. Glasgow Outcome Score - Extended (GOS-E) [3 and 6 months post injury]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. TBI diagnosed by history and/or clinical examination with presenting GCS between 9 -13

    2. Age between 18 and 55 years

    3. Frontal cerebral contusion(s) located in the frontal cortex and/or traumatic subarachnoid hemorrhage on initial CT scan

    4. Prior to randomization, patient is able to swallow an orally administered tablet or has a nasogastric tube in place per medical indication

    5. Informed consent will be obtained in those patients who have regained full cognition and judgment following their injury and are fully capable of understanding the study protocol, its risks and potential benefits, and of giving informed consent for participation in the study. In any patient that has not regained full cognition and judgment, only a temporary legal guardian (apotropos) appointed by an authorized judge that has been given a full explanation of the study protocol, its risks and potential benefits will be authorized to give informed consent for participation in the study.

    Exclusion Criteria:

    1. Penetrating brain injury

    2. Any traumatic intracranial lesion requiring neurosurgical intervention prior to time of randomization

    3. Other severe systemic injuries leading to severe hypotension, hemodynamic instability following initial resuscitation (SBP < 90 mmHg), severe hypoxia.

    4. Intubation lasting > 12 hours prior to randomization

    5. Suspected or confirmed pregnancy or lactating women

    6. Any spinal cord injury

    7. Known or CT scan evidence of previous major cerebral damage

    8. Any severe concomitant condition (malignancy, renal, hepatic, or major psychiatric disorder)

    9. Known treatment with another investigational drug within 30 days of injury

    10. Known contraindication to enteral administration of drug prior to randomization (GI bleed, ileus, severe abdominal injury, etc.)

    11. Known contraindication to placement of a nasogastric tube in patients unable to swallow an orally administered tablet

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rambam Medical Center Haifa Israel
    2 Hadassah Medical Center Jerusalem Israel 91120
    3 Sheba Medical Center Ramat Gan Israel

    Sponsors and Collaborators

    • Hadassah Medical Organization

    Investigators

    • Principal Investigator: Guy Rosenthal, MD, Hadassah Medical Organization

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01343862
    Other Study ID Numbers:
    • 0046-10-HMO
    First Posted:
    Apr 28, 2011
    Last Update Posted:
    Apr 28, 2011
    Last Verified:
    Apr 1, 2011
    Keywords provided by , ,
    moderate traumatic brain injury
    brain contusion
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Cycloserine

    Study Results

    No Results Posted as of Apr 28, 2011