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Completed

NCT Number: NCT01860404

BCAA Supplementation for Concussion

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.

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Key information

Age range

11 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females, ages 11 - 34 years, of any race.
  • Subjects who had a concussion, as diagnosed by a qualified physician, within 72 hours prior to enrollment.
  • Ability to have daily email and internet access.
  • Females must have a negative urine pregnancy test and must use an acceptable method of contraception.
  • Subjects must, in the opinion of the referring physician, have the capacity to provide informed consent.
  • 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 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.
  • 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 Food, Drug, and Cosmetic (FD&C) Red #40 (red dye 40) or Sucralose.
  • Lactating females.
  • Parents/guardians or subjects who, in the opinion of the investigators, may be non-compliant with study schedules or procedures.

Treatment and study plan

Branched Chain Amino Acids

Drug

The three BCAA's will be combined together and dissolved in a flavored solution.

Placebo solution

Drug

The placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution.

Primary outcomes

  1. Reaction Time Difference Between Drug and Placebo Groups

    Time frame: Day 21

    Processing speed subtest of the Axon Sports Computerized Cognitive Assessment Tool. The values provided are the median of log reaction time to the processing speed subtest, where a lower score indicates a faster time and thus improved processing speed.

Secondary outcomes

  1. Clinical Symptoms

    Time frame: Day 21

    Evaluate whether BCAA supplementation reduces total symptom burden on a total symptom scale of 9 concussion symptoms rated each from 0-6, minimal value 0, maximum value 54, a higher score indicates a higher symptom burden and therefore a worse outcome

  2. Return to Physical Activity Baseline

    Time frame: Day 21

    Determine whether BCAA supplementation more rapidly facilitates a return to physical baseline. The physical activity score is scaled on a 6 point Likert scale (0-5), where 0 represents no activity and 5 represents full activity, therefore a higher score represents a closer return to baseline activity by the end of the study period

  3. Neurocognitive Recovery-- Attention

    Time frame: Day 21

    Determine whether administration of BCAAs improves the median log reaction time of the attention subtest of the neurocognitive testing battery. A lower median log reaction time represents improved attention

  4. Compliance and Adherence to Treatment

    Time frame: Day 21

    Adherence to treatment among dosage groups, reported as the median percent drink consumed among the group across the study period, where 100% = all drink (2 doses per day x 21 days) consumed, and 0% represents no drink consumed

  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, measured as the percent of participants in each study arm reporting adverse events

  6. Safety and BCAA Supplementation

    Time frame: Day 21

    Asses the safety of BCAA doses in concussed athletes through subject reported serious adverse events (SAEs). Reported as the number of participants in each arm experiencing an SAE.

  7. Neurocognitive Recovery-- Working Memory

    Time frame: Day 21

    Determine whether administration of BCAAs improves the the median of log reaction time of the working memory subtest of the neurocognitive testing battery. A lower median log reaction time represents improved working memory.

  8. Neurocognitive Recovery-- Visual Memory

    Time frame: Day 21

    Determine whether administration of BCAAs improves the accuracy score of the visual memory subtest of the neurocognitive testing battery. A higher accuracy score (scaled 0-1.5) represents improved visual memory

  9. Return to Baseline Cognitive Activity

    Time frame: Day 21

    Determine whether BCAA supplementation more rapidly facilitates a return to cognitive activity baseline. The cognitive activity score is scaled on a 5 point Likert scale (0-4), where 0 represents no activity and 4 represents full activity, therefore a higher score represents a closer return to baseline cognitive activity by the end of the study period

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Main Line Health
  • Pennsylvania Department of Health
  • The Dana Foundation
  • University of Pennsylvania

Registry information

Official study 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

Acronym: HIT_HEADS

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
May 22, 2013
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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