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BCAAs in Concussion 3.0

RecruitingPhase 2Healthy volunteers welcome

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

Who can join

Ages 11 to 23 · All sexes · Healthy volunteers welcome

Full eligibility criteria
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 requiring hospital admission, or TBI requiring neurosurgical intervention.
2. Prior concussion or TBI within 90 days.
3. Known history of maple syrup urine disease or known family history of maple syrup urine disease.
4. Any investigational drug use within 30 days prior to enrollment.
5. Participants who are pregnant, planning on becoming pregnant during the study duration, or breastfeeding.
6. Non-English speaking participants or parent/guardian.

About the study

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.

What is being tested

Sponsor: Akiva Cohen · Participants: 150 · Started: Aug 5, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07670195

Locations in the U.S.

PennsylvaniaChildren's Hospital of Philadelphia, Havertown

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.