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

This study is not yet open for participant recruitment.
Verified April 2011 by Hadassah Medical Organization
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01343862
First received: April 27, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate TBI Patients

Resource links provided by NLM:

Drug Information available for: Cycloserine
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • A battery of neuropsychological tests at 3 and 6 months post-injury [ Time Frame: 3 and 6 months post-injury ] [ Designated as safety issue: No ]
    • 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:
  • Glasgow Outcome Score - Extended (GOS-E) [ Time Frame: 3 and 6 months post injury ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343862

Contacts
Contact: Guy Rosenthal, MD 972-2-677-7092 rosenthalg@hadassah.org.il

Locations
Israel
Rambam Medical Center Not yet recruiting
Haifa, Israel
Contact: Leon Levi, MD         llevi@rambam.health.gov.il    
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            
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Guy Rosenthal, MD Hadassah Medical Center
  More Information

No publications provided

Responsible Party: Guy Rosenthal, MD, Hadassah-Hebrew University Medical Center, Department of Neurosurgery, Hadassah-Hebrew University Medical Center
ClinicalTrials.gov Identifier: NCT01343862     History of Changes
Other Study ID Numbers: 0046-10-HMO
Study First Received: April 27, 2011
Last Updated: April 27, 2011
Health Authority: Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on May 19, 2013