BCAA's in Sports-related Concussion (HIT HEADS)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
The Dana Foundation
Main Line Health
University of Pennsylvania
Information provided by (Responsible Party):
Matthew Kirschen, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01860404
First received: May 20, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Brain Concussion
Drug: Branched Chain Amino Acids
Drug: Placebo solution
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Reaction time difference between drug and placebo groups [ Time Frame: Days 3-6, 7-10, 11-14 ] [ Designated as safety issue: No ]
    Processing speed subtest of the Axon Sports Computerized Cognitive Assessment Tool


Secondary Outcome Measures:
  • Clinical symptoms [ Time Frame: Days 3-6, 7-10, 11-14 ] [ Designated as safety issue: No ]
    Evaluate whether BCAA supplementation reduces the time to clinical symptom resolution.

  • Return to school and sports [ Time Frame: Days 3-6, 7-10, 11-14 ] [ Designated as safety issue: No ]
    Determine whether BCAA supplementation reduces the time to return to school or work, and participation in sports.

  • Neurocognitive recovery [ Time Frame: Days 3-6, 7-10, 11-14 ] [ Designated as safety issue: No ]
    Determine whether administration of BCAA's reduces the time for neurocognitive recovery for the cognitive domains of attention, learning, and working memory, which are the additional subcomponents of the Axon Sports Computerized Cognitive Assessment Tool.

  • Compliance and Adherence to Treatment [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    Adherence to treatment among dosage groups versus placebo and as a function of time.

  • Tolerability of BCAA's Based on Adverse Events [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
    Assess the tolerability of BCAA doses based on subject reported adverse events.

  • Safety and BCAA Supplementation [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
    Asses the safety of BCAA doses in concussed athletes through subject reported adverse events (AEs)and serious adverse events (SAEs).


Estimated Enrollment: 50
Study Start Date: January 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo will be administered orally twice daily for 21 days
Drug: Placebo solution
The placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution.
Experimental: Branched Chain Amino Acids (30g BID)
30 grams of BCAA's will be administered twice-daily for 21 days
Drug: Branched Chain Amino Acids
The three BCAA's will be combined together and dissolved in a flavored solution.
Experimental: Branched Chain Amino Acids (22.5g BID)
22.5 grams of BCAA's will be administered twice-daily for 21 days
Drug: Branched Chain Amino Acids
The three BCAA's will be combined together and dissolved in a flavored solution.
Experimental: Branched Chain Amino Acids (15g BID)
15 grams of BCAA's will be administered twice-daily for 21 days
Drug: Branched Chain Amino Acids
The three BCAA's will be combined together and dissolved in a flavored solution.
Experimental: Branched Chain Amino Acids (7.5g BID)
7.5 grams of BCAA's will be administered twice-daily for 21 days
Drug: Branched Chain Amino Acids
The three BCAA's will be combined together and dissolved in a flavored solution.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 34 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, ages 16 - 34 years, of any race.
  • Subjects who had a sports-related concussion, as diagnosed by a qualified physician, within 48 hours of enrollment. Concussions may be sustained while participating in any sport during either practice or competition.
  • Ability to have daily email and internet access.
  • Women must have a negative urine pregnancy test and must use an acceptable method of contraception including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive for the duration of the study.
  • Subjects must, in the opinion of the referring physician, have the capacity to provide informed consent, defined by: 1) the ability to communicate; 2) the ability to assess their understanding of the treatment; 3) the ability to understand the risks and benefits of the treatment; and 4) the ability to understand the risks and benefits of not embarking on the treatment.
  • Informed consent by the subject, or for subjects <18 years old both informed consent by a parent/guardian and child assent.

Exclusion Criteria:

  • Witnessed seizure at the time of injury or penetrating head injury.
  • Prior concussion or traumatic brain injury (TBI) within 90 days.
  • Concussion or TBI severe enough to require admission to an intensive care unit for observation or intervention.
  • Previous history of TBI or concussion requiring admission to the hospital, disabling stroke, epilepsy, brain tumor, neurodegenerative condition, or psychiatric disease.
  • Subjects taking neurological or psychoactive medications as a regular daily prescription medication (e.g. stimulants, antidepressants, anticonvulsants, benzodiazepines, etc.).
  • Known history of maple syrup urine disease or known family history of maple syrup urine disease.
  • Any investigational drug use within 30 days prior to enrollment.
  • Allergy to Federal Food, Drug, and Cosmetic Act (FD&C) Red #40 (red dye 40) or Sucralose.
  • Lactating women.
  • Parents/guardians or subjects who, in the opinion of the investigators, may be non-compliant with study schedules or procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01860404

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Matthew Kirschen
The Dana Foundation
Main Line Health
University of Pennsylvania
Investigators
Principal Investigator: Matthew Kirschen, MD PhD Children's Hospital of Philadelphia
  More Information

Publications:
Responsible Party: Matthew Kirschen, Attending in Neurology and Fellow in Critical Care Medicine, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01860404     History of Changes
Other Study ID Numbers: 13-10227
Study First Received: May 20, 2013
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration
United States: Children's Hospital of Philadelphia Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Concussion
Branched chain amino acids
BCAA
HIT HEADS

Additional relevant MeSH terms:
Brain Concussion
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014