BCAAs in Concussion 2.0

Launched by AKIVA COHEN · Feb 13, 2025

Keywords

ClinConnect Summary

The BCAAs in Concussion 2.0 trial is studying how branched chain amino acids (BCAAs) might help people recover from concussions. This research is focused on young individuals between the ages of 11 and 23 who have experienced a concussion within the last four days. The goal is to see if taking high doses of BCAAs can speed up recovery compared to a placebo, which is a dummy treatment that looks the same but has no active ingredients.

To participate, candidates need to weigh at least 40 kg and meet specific concussion criteria. They must also be able to provide consent, or if they are under 18, a parent or guardian will need to give permission. However, individuals with more serious brain injuries, those who have had a concussion in the last 90 days, or those with certain medical conditions will not be eligible. The study is not yet recruiting participants, but if you or someone you know meets the criteria, it could be an opportunity to help advance concussion treatment while receiving monitored care.

Gender

ALL

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.
• • 4. Present within 4 days of injury.
• • 5. Post-menarchal females must have a negative urine pregnancy test and must use an acceptable method of contraception.
• • 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 Traumatic Brain Injury (TBI), including Glasgow Coma Scale (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. Hypersensitivity to any ingredient in the active or placebo products.
• • 6. Participants who are pregnant, planning on becoming pregnant during the study duration, or breastfeeding.
• • 7. Non-English speaking participants or parent/guardian.