Clinical trial NCT01860404: BCAA Supplementation for 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 Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain Concussion
Keywords: Concussion
Branched chain amino acids
BCAA
HIT HEADS
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: The Dana Foundation
name: Main Line Health
name: University of Pennsylvania
name: Pennsylvania Department of Health
First posted: 2013-05-22
Enrollment: 42
Sex: ALL
Minimum age (years): 11
Maximum age (years): 34
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Reaction Time Difference Between Drug and Placebo Groups
timeFrame: Day 21
Secondary outcomes:
measure: Clinical Symptoms
timeFrame: Day 21
measure: Return to Physical Activity Baseline
timeFrame: Day 21
measure: Neurocognitive Recovery-- Attention
timeFrame: Day 21
measure: Compliance and Adherence to Treatment
timeFrame: Day 21
measure: Tolerability of BCAA's Based on Adverse Events
timeFrame: Day 21
measure: Safety and BCAA Supplementation
timeFrame: Day 21
measure: Neurocognitive Recovery-- Working Memory
timeFrame: Day 21
measure: Neurocognitive Recovery-- Visual Memory
timeFrame: Day 21
measure: Return to Baseline Cognitive Activity
timeFrame: Day 21
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Sage Myers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.