BCAA's in Sports-related Concussion

Condition(s) targeted: Brain Concussion

Intervention: Branched Chain Amino Acids (Drug); Placebo solution (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Children's Hospital of Philadelphia

Official(s) and/or principal investigator(s):
Matthew Kirschen, MD PhD, Principal Investigator, Affiliation: Children's Hospital of Philadelphia

Overall contact:
Jaclynn Elkind, Phone: 215-590-1472, Email: elkindj1@email.chop.edu

This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAA's) in the treatment of sports-related 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 sports-related concussion improves neurocognitive recovery at one or more time-periods post concussion.

Official title: Head Injury Treatment With Healthy and Advanced Dietary Supplements (HIT HEADS): A Randomized, Placebo-controlled, Double-blinded, Therapeutic Exploratory Clinical Trial of Branched Chain Amino Acids (BCAA's) in the Treatment of Sports-related Concussion

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Reaction time difference between drug and placebo groups

Secondary outcome:

Clinical symptoms

Return to school and sports

Neurocognitive recovery

Compliance and Adherence to Treatment

Tolerability of BCAA's Based on Adverse Events

Safety and BCAA Supplementation

Detailed description:

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 athletes 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 sports-related concussions. The limbic hippocampus, a brain structure crucial for learning and memory, is often damaged in concussion. In preclinical studies, analysis of hippocampi isolated from mice after traumatic brain injury demonstrated that only the concentrations of the three branched chain amino acids (valine, isoleucine, and leucine) were significantly altered (reduced) after injury. When these brain-injured animals received dietary supplementation with branched chain amino acids (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 conducting a therapeutic exploratory clinical trial to determine the effects of BCAA's in reducing the neurocognitive side effects of sports-related concussion injury.

Minimum age: 16 Years. Maximum age: 34 Years. Gender(s): Both.

Criteria:

Inclusion Criteria

1. Males and females, ages 16 - 34 years, of any race.

2. Subjects who had a sports-related concussion, as diagnosed by a qualified physician, within 72 hours prior to enrollment. Concussions may be sustained while participating in any sport during either practice or competition. 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 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.

Jaclynn Elkind, Phone: 215-590-1472, Email: elkindj1@email.chop.edu

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Jaclynn Elkind, Phone: 215-590-1472, Email: elkindj1@email.chop.edu
Matthew Kirschen, MD, PhD, Phone: 215-590-7430, Email: kirschenm@chop.edu
Matthew Kirschen, MD PhD, Principal Investigator
Akiva Cohen, PhD, Sub-Investigator

Related publications:

Cole JT, Mitala CM, Kundu S, Verma A, Elkind JA, Nissim I, Cohen AS. Dietary branched chain amino acids ameliorate injury-induced cognitive impairment. Proc Natl Acad Sci U S A. 2010 Jan 5;107(1):366-71. doi: 10.1073/pnas.0910280107. Epub 2009 Dec 7. Erratum in: Proc Natl Acad Sci U S A. 2010 Feb 2;107(5):2373.

Starting date: January 2014
Last updated: August 6, 2015