BCAAs in Concussion 2.0

Description

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.

Conditions

Concussion, Brain, Concussion, Mild, Concussion

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Study Overview

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Study Details

Study overview

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.

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

BCAAs in Concussion 2.0

Condition
Concussion, Brain
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

11 Years to 23 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Akiva Cohen,

Daniel Corwin, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

2026-08