The Use of Anti-oxidants to Reduce Sequela of Mild Traumatic Brain Injury (mTBI) After Blast Exposure
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): N-acetyl-cysteine (NAC); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Anti-oxidant in a pill format; Control for study
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mild traumatic brain injury; anti-oxidant; early treatment