Using branched chain amino acids to treat concussion

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

This study is testing if high-dose branched chain amino acids can help young people aged 11 to 23 recover faster from a concussion.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 11 Years to 23 Years
• Sex: All
• Sponsor: Children's Hospital of Philadelphia (other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT06829498 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, placebo-controlled, double-blinded investigation into the effects of high-dose branched chain amino acids (BCAAs) on concussion recovery. The study aims to determine if BCAAs can promote recovery in individuals aged 11 to 23 who have sustained a concussion within the last four days. Previous research has indicated that BCAAs may restore cognitive function in brain-injured animals, and this trial seeks to evaluate similar benefits in humans. Participants will be monitored for symptom improvement and return to baseline physical activity levels.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 11 to 23 who have sustained a concussion within the last four days.

Not a fit: Patients with moderate or severe traumatic brain injury or those with a history of concussion within the last 90 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a targeted therapeutic option for individuals recovering from concussions.

How similar studies have performed: Previous studies have shown promising results with BCAAs in reducing concussion symptoms, indicating potential for success in this larger trial.

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.

Where this trial is running

Philadelphia, Pennsylvania

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Daniel Corwin, MD — Children's Hospital of Philadelphia
• Study coordinator: Olivia Podolak

Conditions: Concussion, Brain, Concussion, Mild, Concussion