BCAA Supplementation for Concussion (HIT_HEADS)

Children's Hospital of Philadelphia (CHOP)

Status and phase: Completed; Phase 2

Conditions: Brain Concussion

Treatments: Drug: Placebo solution; Drug: Branched Chain Amino Acids

Study type: Interventional

Funder types: Other

Identifiers

NCT01860404

13-010227

Details and patient eligibility

About

This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAA's) in the treatment of concussion. The aim of the study is to determine whether, compared to placebo treatment, administration of BCAA's, at one or more doses, after a concussion improves neurocognitive recovery at one or more time-periods post concussion.

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: 11 to 34 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo will be administered orally twice daily for 21 days

Treatment:

Drug: Placebo solution

Branched Chain Amino Acids (27g BID)

Experimental group

Description:

27 grams of BCAA's will be administered twice-daily for 21 days

Treatment:

Drug: Branched Chain Amino Acids

Branched Chain Amino Acids (22.5g BID)

Experimental group

Description:

22.5 grams of BCAA's will be administered twice-daily for 21 days

Treatment:

Drug: Branched Chain Amino Acids

Branched Chain Amino Acids (15g BID)

Experimental group

Description:

15 grams of BCAA's will be administered twice-daily for 21 days

Treatment:

Drug: Branched Chain Amino Acids

Branched Chain Amino Acids (7.5g BID)

Experimental group

Description:

7.5 grams of BCAA's will be administered twice-daily for 21 days

Treatment:

Drug: Branched Chain Amino Acids