HIT HEADS 3.0: Head Injury Treatment: A Randomized, Placebo-controlled, Double-blinded, Therapeutic Clinical Trial of Branched Chain Amino Acids (BCAAs) in the Treatment of Concussion
Akiva Cohen
Summary
This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAAs) in the treatment of concussion. The aim of the study is to determine whether administration of high-dose BCAAs compared to placebo promotes concussion recovery.
Description
Annually, approximately 2 million concussions occur in the pediatric and young adult population. Approximately 30% of those diagnosed with concussion will experience persisting symptoms lasting beyond 28 days. Concussion is a heterogeneous injury to the brain that precipitates a complex pathophysiological process that can result in a cascade of deleterious side effects. At present, there are no targeted therapeutics that can mitigate or prevent the deleterious effects of concussion. In preclinical, analysis of ipsilateral hippocampi isolated from mice after traumatic brain injury (TBI) demonst…
Eligibility
- Age range
- 11–23 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Males and females,11 - 23 years of age. 2. Weigh at least 40kg. 3. Meeting concussion criteria for the American Congress of Rehabilitative Medicine. a. One or more clinical signs or two or more acute symptoms with at least one VVE abnormality. 4. Present within 4 days of injury. 5. Post-menarchal females must have a negative urine pregnancy test. 6. Informed consent by the participant, or for participants \<18 years old both informed consent by a parent/guardian and child assent. Exclusion Criteria: 1. Evidence of moderate or severe TBI, including GCS \<13, TBI re…
Interventions
- DrugBCAA
The three BCAAs will be combined together into a powder formulation.
- OtherPlacebo
The placebo formulation will have similar taste, texture, consistency and appearance as the BCAA formulation.
Location
- Children's Hospital of PhiladelphiaHavertown, Pennsylvania