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

August 9, 2010 updated by: Brooke Army Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • AL Taqaddum, Iraq
        • TQ Surgical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
control
Drug: Placebo
Control for study
Experimental: 1
Active medicine
Drug: N-acetyl-cysteine (NAC)
Anti-oxidant in a pill format

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relief of symptoms of mTBI
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Investigators

  • Principal Investigator: Michael E. Hoffer, M.D., U.S. Military

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

August 10, 2010

Last Update Submitted That Met QC Criteria

August 9, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MNC-IRAQ-08-040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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