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BCAA's in Concussion (HIT HEADS)

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ClinicalTrials.gov Identifier: NCT01860404
Recruitment Status : Recruiting
First Posted : May 22, 2013
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
The Dana Foundation
Main Line Health
University of Pennsylvania
Information provided by (Responsible Party):
Sage R Myers, Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Brain Concussion Drug: Branched Chain Amino Acids Drug: Placebo solution Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Concussion
Study Start Date : January 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Concussion
U.S. FDA Resources

Arm Intervention/treatment
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 (27g BID)
27 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.



Primary Outcome Measures :
  1. Reaction time difference between drug and placebo groups [ Time Frame: Days 3-6, 7-10, 11-14 ]
    Processing speed subtest of the Axon Sports Computerized Cognitive Assessment Tool


Secondary Outcome Measures :
  1. Clinical symptoms [ Time Frame: Days 3-6, 7-10, 11-14 ]
    Evaluate whether BCAA supplementation reduces the time to clinical symptom resolution.

  2. Return to school and sports [ Time Frame: Days 3-6, 7-10, 11-14 ]
    Determine whether BCAA supplementation reduces the time to return to school or work, and participation in sports.

  3. Neurocognitive recovery [ Time Frame: Days 3-6, 7-10, 11-14 ]
    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.

  4. Compliance and Adherence to Treatment [ Time Frame: Day 21 ]
    Adherence to treatment among dosage groups versus placebo and as a function of time.

  5. Tolerability of BCAA's Based on Adverse Events [ Time Frame: Day 21 ]
    Assess the tolerability of BCAA doses based on subject reported adverse events.

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



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Ages Eligible for Study:   11 Years to 34 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860404


Contacts
Contact: Jeffrey Berg, BA 267-432-2862 bergj1@email.chop.edu
Contact: Sage Myers, MD 267-426-7939 myerss@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jeffrey Berg    267-432-2862    bergj1@email.chop.edu   
Contact: Sage Myers, MD    267-426-7939    myerss@email.chop.edu   
Principal Investigator: Sage Myers, MD         
Sub-Investigator: Akiva Cohen, PhD         
Sponsors and Collaborators
Children's Hospital of Philadelphia
The Dana Foundation
Main Line Health
University of Pennsylvania
Investigators
Principal Investigator: Sage Myers, MD Children's Hospital of Philadelphia

Publications:
Responsible Party: Sage R Myers, Attending Physician, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01860404     History of Changes
Other Study ID Numbers: 13-10227
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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

Additional relevant MeSH terms:
Brain Concussion
Brain Injuries, Traumatic
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