RECRUITING

BCAAs in Concussion 2.0

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Conditions

Concussion, BrainConcussion, MildConcussion

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-01
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06829498

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.

Ages Eligible for Study:11 Years to 23 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Males and females,11 - 23 years of age.
  2. 2. Weigh at least 40kg.
  3. 3. Meeting concussion criteria for the American Congress of Rehabilitative Medicine.
  4. 4. Present within 4 days of injury.
  5. 5. Post-menarchal females must have a negative urine pregnancy test and must use an acceptable method of contraception.
  6. 6. Informed consent by the participant, or for participants \<18 years old both informed consent by a parent/guardian and child assent.
  1. 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. 2. Prior concussion or TBI within 90 days.
  3. 3. Known history of maple syrup urine disease or known family history of maple syrup urine disease.
  4. 4. Any investigational drug use within 30 days prior to enrollment.
  5. 5. Hypersensitivity to any ingredient in the active or placebo products.
  6. 6. Participants who are pregnant, planning on becoming pregnant during the study duration, or breastfeeding.
  7. 7. Non-English speaking participants or parent/guardian.

Contacts and Locations

Study Contact

Olivia Podolak
CONTACT
8626687645
podolako@chop.edu

Principal Investigator

Daniel Corwin, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Akiva Cohen

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2026-08

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

  • Concussion, Brain
  • Concussion, Mild
  • Concussion