BCAA Supplementation for Concussion

Phase 2

Completed

Conditions: Brain Concussion

Interventions: Drug: Placebo solution
Drug: Branched Chain Amino Acids

Registration Number: NCT01860404

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo solution	Placebo will be administered orally twice daily for 21 days
Branched Chain Amino Acids (27g BID)	Branched Chain Amino Acids	27 grams of BCAA's will be administered twice-daily for 21 days
Branched Chain Amino Acids (15g BID)	Branched Chain Amino Acids	15 grams of BCAA's will be administered twice-daily for 21 days
Branched Chain Amino Acids (22.5g BID)	Branched Chain Amino Acids	22.5 grams of BCAA's will be administered twice-daily for 21 days
Branched Chain Amino Acids (7.5g BID)	Branched Chain Amino Acids	7.5 grams of BCAA's will be administered twice-daily for 21 days

Primary Outcome Measures

Name	Time	Method
Reaction Time Difference Between Drug and Placebo Groups	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 Outcome Measures

Name	Time	Method
Tolerability of BCAA's Based on Adverse Events	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
Return to Physical Activity Baseline	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
Neurocognitive Recovery-- Attention	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
Compliance and Adherence to Treatment	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
Neurocognitive Recovery-- Working Memory	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.
Neurocognitive Recovery-- Visual Memory	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
Clinical Symptoms	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
Safety and BCAA Supplementation	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.
Return to Baseline Cognitive Activity	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