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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Hadassah Medical Organization

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
Traumatic Brain Injury Drug: D-cycloserine Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2011
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Arm Intervention/treatment
Experimental: D- Cycloserine Drug: D-cycloserine
single dose of D-cycloserine given 48-72 hours after moderate traumatic brain injury
Other Name: 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

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Glasgow Outcome Score - Extended (GOS-E) [ Time Frame: 3 and 6 months post injury ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01343862

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Contact: Guy Rosenthal, MD 972-2-677-7092

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Rambam Medical Center Not yet recruiting
Haifa, Israel
Contact: Leon Levi, MD   
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   
Principal Investigator: Nachshon Knoller, MD         
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Guy Rosenthal, MD Hadassah Medical Center

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Responsible Party: Guy Rosenthal, MD, Hadassah-Hebrew University Medical Center, Department of Neurosurgery, Hadassah-Hebrew University Medical Center Identifier: NCT01343862     History of Changes
Other Study ID Numbers: 0046-10-HMO
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: April 2011

Keywords provided by Hadassah Medical Organization:
moderate traumatic brain injury
brain contusion

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action