BCAAs in Concussion 3.0
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BCAA, Placebo.
- Who it may be relevant to
- Registry conditions: Concussion (Diagnosis), MTBI - Mild Traumatic Brain Injury, Concussion, Brain, Concussion. Basic parameters: 11 years — 23 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Detailed description
Annually, approximately 2 million concussions occur in the pediatric and young adult population. Approximately 30% of those diagnosed with concussion will experience persisting symptoms lasting beyond 28 days. Concussion is a heterogeneous injury to the brain that precipitates a complex pathophysiological process that can result in a cascade of deleterious side effects. At present, there are no targeted therapeutics that can mitigate or prevent the deleterious effects of concussion. In preclinical, analysis of ipsilateral hippocampi isolated from mice after traumatic brain injury (TBI) demonstrated that only the concentrations of the three branched chain amino acids (BCAAs) (valine, isoleucine, and leucine) were significantly reduced after injury. When these brain-injured animals received dietary supplementation with BCAAs, the concentrations of these amino acids were restored in the injured hippocampus and the injured animals demonstrated significant cognitive improvement to levels comparable to those obtained in non-injured control animals. The pilot study (NCT01860404) provides evidence of BCAAs in concussed adolescents and young adults providing a dose-response effect in reducing concussion symptoms and a return to baseline physical activity in those treated with higher total doses of BCAAs. This third trial was developed to inform clinical practice around BCAA treatment in concussion in a new formulation.
Interventions
- Drug BCAA
The three BCAAs will be combined together into a powder formulation. - Other Placebo
The placebo formulation will have similar taste, texture, consistency and appearance as the BCAA formulation.
Primary outcome measures
- Number of participants that have met have met criteria for recovery at 28 days post-injury, defined as return to baseline symptom levels along with feeling > 90% back to normal. [Time frame: 28 days]
Secondary outcome measures (12)
- Determine whether administration of high-dose BCAAs (30g/day) compared to placebo supplementation, promotes concussion recovery operationalized by the return to baseline (pre-injury) concussion symptom levels. [Time frame: 28 days]
- Determine whether administration of BCAAs leads to a lower visio-vestibular abnormality burden compared to placebo. [Time frame: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities--maximum pupil diameter compared to placebo. [Time frame: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities--minimum pupil diameter compared to placebo. [Time frame: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-percentage of pupil constriction compared to placebo. [Time frame: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-constriction latency compared to placebo. [Time frame: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-average constriction velocity compared to placebo. [Time frame: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities--peak constriction velocity compared to placebo. [Time frame: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-average dilation velocity compared to placebo. [Time frame: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-peak dilation velocity compared to placebo. [Time frame: 28 days]
- Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-T75 compared to placebo. [Time frame: 28 days]
- Determine whether administration of BCAAs leads to subjective improvement in sleep quality compared to placebo. [Time frame: 28 days]
Eligibility criteria
Inclusion criteria
- Males and females,11 - 23 years of age.
- Weigh at least 40kg.
- 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.
- Present within 4 days of injury.
- Post-menarchal females must have a negative urine pregnancy test.
- Informed consent by the participant, or for participants <18 years old both informed consent by a parent/guardian and child assent.
Exclusion criteria
- Evidence of moderate or severe TBI, including GCS <13, TBI requiring hospital admission, or TBI requiring neurosurgical intervention.
- Prior concussion or TBI within 90 days.
- Known history of maple syrup urine disease or known family history of maple syrup urine disease.
- Any investigational drug use within 30 days prior to enrollment.
- Participants who are pregnant, planning on becoming pregnant during the study duration, or breastfeeding.
- Non-English speaking participants or parent/guardian.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Corwin DJ, Myers SR, Arbogast KB, Lim MM, Elliott JE, Metzger KB, LeRoux P, Elkind J, Metheny H, Berg J, Pettijohn K, Master CL, Kirschen MP, Cohen AS. Head Injury Treatment With Healthy and Advanced Dietary Supplements: A Pilot Randomized Controlled Trial of the Tolerability, Safety, and Efficacy of Branched Chain Amino Acids in the Treatment of Concussion in Adolescents and Young Adults. J Neuro PMID 38468511
Identifiers
NCT: NCT07670195 · 23-024503