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
Overview
- Phase
- Phase 2
- Intervention
- Placebo solution
- Conditions
- Brain Concussion
- Sponsor
- Children's Hospital of Philadelphia
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Reaction Time Difference Between Drug and Placebo Groups
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Sage R Myers
Attending Physician
Children's Hospital of Philadelphia
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Placebo will be administered orally twice daily for 21 days
Intervention: Placebo solution
Branched Chain Amino Acids (27g BID)
27 grams of BCAA's will be administered twice-daily for 21 days
Intervention: Branched Chain Amino Acids
Branched Chain Amino Acids (22.5g BID)
22.5 grams of BCAA's will be administered twice-daily for 21 days
Intervention: Branched Chain Amino Acids
Branched Chain Amino Acids (15g BID)
15 grams of BCAA's will be administered twice-daily for 21 days
Intervention: Branched Chain Amino Acids
Branched Chain Amino Acids (7.5g BID)
7.5 grams of BCAA's will be administered twice-daily for 21 days
Intervention: Branched Chain Amino Acids
Outcomes
Primary Outcomes
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
- Tolerability of BCAA's Based on Adverse Events(Day 21)
- Return to Physical Activity Baseline(Day 21)
- Neurocognitive Recovery-- Attention(Day 21)
- Compliance and Adherence to Treatment(Day 21)
- Neurocognitive Recovery-- Working Memory(Day 21)
- Neurocognitive Recovery-- Visual Memory(Day 21)
- Clinical Symptoms(Day 21)
- Safety and BCAA Supplementation(Day 21)
- Return to Baseline Cognitive Activity(Day 21)