BCAA's in Concussion

Annually, between 100,000 to 140,000 children present to the emergency department for
concussion in the United States.1 The Centers for Disease Control now estimates that 1.6 -
3.8 million sports related concussions occur each year in the United States. A large
proportion of these patients have enduring cognitive and neurobehavioral problems. Concussion
is a heterogeneous insult to the brain that precipitates a complex pathophysiological process
that can result in a cascade of deleterious side effects. At present, there are no proven
therapies to mitigate or prevent the neurocognitive and neurobehavioral consequences of
concussions. The limbic hippocampus, a brain structure crucial for learning and memory, is
often damaged in concussion. In preclinical studies in our laboratory, analysis of
ipsilateral hippocampi isolated from mice after traumatic brain injury (TBI) demonstrated
that only the concentrations of the three BCAA's (valine, isoleucine, and leucine) were
significantly altered (reduced) after injury. When these brain-injured animals received
dietary supplementation with BCAA's, the concentrations of these amino acids were restored in
the injured hippocampus and the injured animals demonstrated significant cognitive
improvement to levels comparable to those obtained in non-injured control animals. In light
of these results and the increasing awareness and morbidity associated with concussion, we
are proposing a pilot therapeutic exploratory clinical trial to determine the effects of
BCAA's in reducing the neurocognitive side effects of concussion injury.

Inclusion Criteria

1. Males and females, ages 11 - 34 years, of any race.

2. Subjects who had a concussion, as diagnosed by a qualified physician, within 72 hours
prior to enrollment.

3. Ability to have daily email and internet access.

4. Females must have a negative urine pregnancy test and must use an acceptable method of
contraception.

5. Subjects must, in the opinion of the referring physician, have the capacity to provide
informed consent.

6. Informed consent by the subject, or for subjects <18 years old both informed consent
by a parent/guardian and child assent.

Exclusion Criteria

1. Witnessed seizure at the time of injury or penetrating head injury.

2. Prior concussion or TBI within 90 days.

3. Concussion or TBI severe enough to require admission to an intensive care unit for
observation or intervention.

4. Previous history of TBI or concussion requiring admission to the hospital, disabling
stroke, epilepsy, brain tumor, neurodegenerative condition, or psychiatric disease.

5. Subjects taking neurological or psychoactive medications as a regular daily
prescription medication.

6. Known history of maple syrup urine disease or known family history of maple syrup
urine disease.

7. Any investigational drug use within 30 days prior to enrollment.

8. Allergy to Food, Drug, and Cosmetic (FD&C) Red #40 (red dye 40) or Sucralose.

9. Lactating females.

10. Parents/guardians or subjects who, in the opinion of the investigators, may be
non-compliant with study schedules or procedures.