BCAAs in Concussion 2.0
HIT HEADS 2.0: 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
150 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Males and females,11 - 23 years of age.
- Weigh at least 40kg.
- Meeting concussion criteria for the American Congress of Rehabilitative Medicine.
- Present within 4 days of injury.
- Post-menarchal females must have a negative urine pregnancy test and must use an acceptable method of contraception.
- Informed consent by the participant, or for participants \<18 years old both informed consent by a parent/guardian and child assent.
Exclusion Criteria7
- Evidence of moderate or severe Traumatic Brain Injury (TBI), including Glasgow Coma Scale (GCS) \<13, TBI requiring hospital admission, or TBI requiring neurosurgical intervention.
- Prior concussion or TBI within 90 days.
- 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.
- Hypersensitivity to any ingredient in the active or placebo products.
- Participants who are pregnant, planning on becoming pregnant during the study duration, or breastfeeding.
- Non-English speaking participants or parent/guardian.
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Interventions
The three BCAAs will be combined together and dissolved in a flavored solution.
The placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06829498