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

Traumatic Brain Injury Clinical Trial

— DCS  

Official title:

The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate TBI Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01343862
• Other study ID #: 0046-10-HMO
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 27, 2011
• Last updated: April 27, 2011
• Start date: August 2011
• Est. completion date: May 2014

Study information

• Verified date: April 2011
• Source: Hadassah Medical Organization
• Contact: Guy Rosenthal, MD
• Phone: 972-2-677-7092
• Email: rosenthalg[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Drug:
• D-cycloserine
single dose of D-cycloserine given 48-72 hours after moderate traumatic brain injury
• placebo
A sugar pill will be given to those patients randomized to the control group at 48-72 hours after moderate brain injury

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 and 6 months post-injury	No
Secondary	Glasgow Outcome Score - Extended (GOS-E)		3 and 6 months post injury	No