HIT HEADS: BCAA's in Concussion

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Recruiting

CT.gov ID

NCT01860404

Collaborator

The Dana Foundation (Other), Main Line Health (Other), University of Pennsylvania (Other), Pennsylvania Department of Health (Other)

Enrollment

Location

Arms

108

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2014

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Reaction time difference between drug and placebo groups [Days 3-6, 7-10, 11-14]
Processing speed subtest of the Axon Sports Computerized Cognitive Assessment Tool

Secondary Outcome Measures

Clinical symptoms [Days 3-6, 7-10, 11-14]
Evaluate whether BCAA supplementation reduces the time to clinical symptom resolution.
Return to school and sports [Days 3-6, 7-10, 11-14]
Determine whether BCAA supplementation reduces the time to return to school or work, and participation in sports.
Neurocognitive recovery [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.
Compliance and Adherence to Treatment [Day 21]
Adherence to treatment among dosage groups versus placebo and as a function of time.
Tolerability of BCAA's Based on Adverse Events [Day 21]
Assess the tolerability of BCAA doses based on subject reported adverse events.
Safety and BCAA Supplementation [Day 21]
Asses the safety of BCAA doses in concussed athletes through subject reported adverse events (AEs)and serious adverse events (SAEs).

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 34 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.