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

This study has been completed.
Sponsor:
Information provided by:
Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT00822263
First received: January 13, 2009
Last updated: August 9, 2010
Last verified: January 2009
  Purpose

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.


Condition Intervention
Mild Traumatic Brain Injury
Drug: N-acetyl-cysteine (NAC)
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Anti-oxidants to Reduce Sequela of Mild TBI (mTBI) After Blast Exposure

Resource links provided by NLM:


Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • Relief of symptoms of mTBI [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2008
Study Completion Date: August 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
control
Drug: Placebo
Control for study
Experimental: 1
Active medicine
Drug: N-acetyl-cysteine (NAC)
Anti-oxidant in a pill format

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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822263

Locations
Iraq
TQ Surgical
AL Taqaddum, Iraq
Sponsors and Collaborators
Brooke Army Medical Center
Investigators
Principal Investigator: Michael E. Hoffer, M.D. U.S. Military
  More Information

No publications provided by Brooke Army Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael E. Hoffer, CAPT MC USN, U.S. Military
ClinicalTrials.gov Identifier: NCT00822263     History of Changes
Other Study ID Numbers: MNC-IRAQ-08-040
Study First Received: January 13, 2009
Last Updated: August 9, 2010
Health Authority: United States: Federal Government

Keywords provided by Brooke Army Medical Center:
mild traumatic brain injury
anti-oxidant
early treatment

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Acetylcysteine
N-monoacetylcystine
Antioxidants
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on August 19, 2014