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The Use of Anti-oxidants to Reduce Sequela of Mild Traumatic Brain Injury (mTBI) After Blast Exposure

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ClinicalTrials.gov Identifier: NCT00822263
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : August 10, 2010
Sponsor:
Information provided by:
Brooke Army Medical Center

January 13, 2009
January 14, 2009
August 10, 2010
November 2008
March 2009   (Final data collection date for primary outcome measure)
Relief of symptoms of mTBI [ Time Frame: 7 days ]
Same as current
Complete list of historical versions of study NCT00822263 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Use of Anti-oxidants to Reduce Sequela of Mild Traumatic Brain Injury (mTBI) After Blast Exposure
The Use of Anti-oxidants to Reduce Sequela of Mild TBI (mTBI) After Blast Exposure
The administration of N-acetyl-cysteine (an anti-oxidant) for seven days along with observation will result in improved hearing and balance function in individuals who demonstrate these disorders after blast exposure when compared to a placebo medicine and observation at the seven day time point.

5.0 RESEARCH PLAN: The goal of this study is to examine the use of one anti-oxidant, N acetylcysteine (NAC), in individuals who suffer blast injury and demonstrate early sequela of mTBI.

Recent changes in war fighting and operational situations have changed the injury patterns that our troops face in all aspects of military operations. Mild traumatic brain injury (mTBI) is among the most common injuries seen in the current theater of operations. While other injury patterns have shown a decrease over the last twelve months, mTBI from blast exposure has continued to be seen at increasing levels. This may be due in part to the fact that research has shown the individuals may suffer mTBI secondary to blast injury from one significant exposure or from repeated low level exposure which is more common as individuals rotate back to the theatre of operations for second, third, and even forth tours of duty. The sequela of mTBI include balance disorders, hearing loss, and cognitive dysfunction. These disorders can present immediately after the injury or several weeks after the injury but tests of function can detect injury shortly after the injury. Evidence exists in laboratory work and in human studies that anti-oxidant medicine can reduce/eliminate the sequela of mTBI if administered within 8-24 hours of injury.

5.1 OBJECTIVES: A population and single-subject design, double blinded, placebo controlled study comparing the effectiveness of the observation and administration of the anti-oxidant NAC to placebo in individuals suffering the sequela of mTBI after a single or multiple blast exposures.

5.2 HYPOTHESIS: The administration of NAC for seven days along with observation will result in improved hearing and balance function in individuals who demonstrate these disorders after blast exposure when compared to a placebo medicine and observation at the seven day time point

5.3 SPECIFIC AIMS:

  1. To determine the frequency of hearing loss and balance disorders in those exposed to blast injury that have non-emergent or non-urgent medical or surgical disorders and display a pattern of injury consistent with mTBI.
  2. To determine the effectiveness of one week of anti-oxidant, N-acetylcysteine combined with observation, in the reduction of hearing loss and balance disorders one week after injury as compared to placebo medication and observation.
  3. To determine the effectiveness of one week of anti-oxidant, N-acetylcysteine combined with observation, in the reduction of hearing loss and balance disorders six months after injury as compared to one week of placebo medication and observation.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Mild Traumatic Brain Injury
  • Drug: N-acetyl-cysteine (NAC)
    Anti-oxidant in a pill format
  • Drug: Placebo
    Control for study
  • Placebo Comparator: 2
    control
    Intervention: Drug: Placebo
  • Experimental: 1
    Active medicine
    Intervention: Drug: N-acetyl-cysteine (NAC)
Hoffer ME, Balaban C, Slade MD, Tsao JW, Hoffer B. Amelioration of acute sequelae of blast induced mild traumatic brain injury by N-acetyl cysteine: a double-blind, placebo controlled study. PLoS One. 2013;8(1):e54163. doi: 10.1371/journal.pone.0054163. Epub 2013 Jan 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
Same as current
August 2009
March 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Be active duty United States Service member
  2. Be between the ages of 18 and 50 years
  3. Present to TQ Surgical within 24 hours of blast exposure.
  4. Have complains consistent with possible TBI including hearing loss, dizziness, lightheadedness, cognitive difficulties, and/or had loss of consciousness.
  5. Are not expressly excluded by the criteria listed below.

Exclusion Criteria:

  1. Require urgent or emergent surgical procedures.
  2. Will require medical evacuation to any level III or higher facility (other then to a level III for a CT scan only).
  3. Has evidence of an open head wound.
  4. Pregnant Females
  5. The use, within the last seven days, of a nutritional supplement containing an anti-oxidant.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Iraq
 
 
NCT00822263
MNC-IRAQ-08-040
Yes
Not Provided
Not Provided
Michael E. Hoffer, CAPT MC USN, U.S. Military
Brooke Army Medical Center
Not Provided
Principal Investigator: Michael E. Hoffer, M.D. U.S. Military
Brooke Army Medical Center
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP