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

Primary Purpose

Traumatic Brain Injury

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
D-cycloserine
placebo
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring moderate traumatic brain injury, brain contusion

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rambam Medical Center
  • Hadassah Medical Center
  • Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

D- Cycloserine

sugar pill

Arm Description

Outcomes

Primary Outcome Measures

A battery of neuropsychological tests at 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

Glasgow Outcome Score - Extended (GOS-E)

Full Information

First Posted
April 27, 2011
Last Updated
April 27, 2011
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01343862
Brief Title
The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate Traumatic Brain Injury (TBI) Patients
Acronym
DCS
Official Title
The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate TBI Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
moderate traumatic brain injury, brain contusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
D- Cycloserine
Arm Type
Experimental
Arm Title
sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
D-cycloserine
Other Intervention Name(s)
seromycin
Intervention Description
single dose of D-cycloserine given 48-72 hours after moderate traumatic brain injury
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
A sugar pill will be given to those patients randomized to the control group at 48-72 hours after moderate brain injury
Primary Outcome Measure Information:
Title
A battery of neuropsychological tests at 3 and 6 months post-injury
Description
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)
Time Frame
3 and 6 months post-injury
Secondary Outcome Measure Information:
Title
Glasgow Outcome Score - Extended (GOS-E)
Time Frame
3 and 6 months post injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: TBI diagnosed by history and/or clinical examination with presenting GCS between 9 -13 Age between 18 and 55 years Frontal cerebral contusion(s) located in the frontal cortex and/or traumatic subarachnoid hemorrhage on initial CT scan Prior to randomization, patient is able to swallow an orally administered tablet or has a nasogastric tube in place per medical indication 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: Penetrating brain injury Any traumatic intracranial lesion requiring neurosurgical intervention prior to time of randomization Other severe systemic injuries leading to severe hypotension, hemodynamic instability following initial resuscitation (SBP < 90 mmHg), severe hypoxia. Intubation lasting > 12 hours prior to randomization Suspected or confirmed pregnancy or lactating women Any spinal cord injury Known or CT scan evidence of previous major cerebral damage Any severe concomitant condition (malignancy, renal, hepatic, or major psychiatric disorder) Known treatment with another investigational drug within 30 days of injury Known contraindication to enteral administration of drug prior to randomization (GI bleed, ileus, severe abdominal injury, etc.) Known contraindication to placement of a nasogastric tube in patients unable to swallow an orally administered tablet
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guy Rosenthal, MD
Phone
972-2-677-7092
Email
rosenthalg@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Rosenthal, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leon Levi, MD
Email
llevi@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Leon Levi, MD
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Rosenthal, MD
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nachshon Knoller, MD
Email
Knoller@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Nachshon Knoller, MD

12. IPD Sharing Statement

Learn more about this trial

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

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