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Brain ConcussionPhase 2HIT_HEADSNCT01860404

BCAA Supplementation for Concussion

A Phase 2 study testing Branched Chain Amino Acids in people with Brain Concussion, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAA's) in the treatment of concussion. The aim of the study is to determine whether, compared to placebo treatment, administration of BCAA's, at one or more doses, after a concussion… Read more about this study

Who is it for?
Ages 11 to 34 years
Conditions the study is for
Brain Concussion
What is being tested?
Branched Chain Amino Acids
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteUnited States
Study dates
Jan 2014to Jan 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 34 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Males and females, ages 11 - 34 years, of any race.
  • Subjects who had a concussion, as diagnosed by a qualified physician, within 72 hours prior to enrollment.
  • Ability to have daily email and internet access.
  • Females must have a negative urine pregnancy test and must use an acceptable method of contraception.
  • Subjects must, in the opinion of the referring physician, have the capacity to provide informed consent.
  • Informed consent by the subject, or for subjects <18 years old both informed consent by a parent/guardian and child assent.

Who cannot join

  • Witnessed seizure at the time of injury or penetrating head injury.
  • Prior concussion or TBI within 90 days.
  • Concussion or TBI severe enough to require admission to an intensive care unit for observation or intervention.
  • Previous history of TBI or concussion requiring admission to the hospital, disabling stroke, epilepsy, brain tumor, neurodegenerative condition, or psychiatric disease.
  • Subjects taking neurological or psychoactive medications as a regular daily prescription medication.
  • Known history of maple syrup urine disease or known family history of maple syrup urine disease.
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  • Any investigational drug use within 30 days prior to enrollment.
  • Allergy to Food, Drug, and Cosmetic (FD\&C) Red #40 (red dye 40) or Sucralose.
  • Lactating females.
  • Parents/guardians or subjects who, in the opinion of the investigators, may be non-compliant with study schedules or procedures.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Head Injury Treatment With Healthy and Advanced Dietary Supplements (HIT HEADS): A Randomized, Placebo-controlled, Double-blinded, Therapeutic Exploratory Clinical Trial of Branched Chain Amino Acids (BCAA's) in the Treatment of Concussion

This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAA's) in the treatment of concussion. The aim of the study is to determine whether, compared to placebo treatment, administration of BCAA's, at one or more doses, after a concussion improves neurocognitive recovery at one or more time-periods post concussion.

Read the detailed description

Annually, between 100,000 to 140,000 children present to the emergency department for concussion in the United States.1 The Centers for Disease Control now estimates that 1.6 - 3.8 million sports related concussions occur each year in the United States. A large proportion of these patients have enduring cognitive and neurobehavioral problems. Concussion is a heterogeneous insult to the brain that precipitates a complex pathophysiological process that can result in a cascade of deleterious side effects. At present, there are no proven therapies to mitigate or prevent the neurocognitive and neurobehavioral consequences of concussions. The limbic hippocampus, a brain structure crucial for learning and memory, is often damaged in concussion. In preclinical studies in our laboratory, analysis of ipsilateral hippocampi isolated from mice after traumatic brain injury (TBI) demonstrated that only the concentrations of the three BCAA's (valine, isoleucine, and leucine) were significantly altered (reduced) after injury. When these brain-injured animals received dietary supplementation with BCAA's, 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. In light of these results and the increasing awareness and morbidity associated with concussion, we are proposing a pilot therapeutic exploratory clinical trial to determine the effects of BCAA's in reducing the neurocognitive side effects of concussion injury.

Being tested
Branched Chain Amino Acids, Placebo solution
Keywords
Concussion, Branched chain amino acids, BCAA, HIT HEADS
Medical subject headings
Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Branched Chain Amino AcidsDrug

    The three BCAA's will be combined together and dissolved in a flavored solution.

  • Placebo solutionDrug

    The placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution.

Study groups in NCT01860404
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo will be administered orally twice daily for 21 days
Receives: Drug: Placebo solution
Branched Chain Amino Acids (27g BID)Experimental27 grams of BCAA's will be administered twice-daily for 21 days
Receives: Drug: Branched Chain Amino Acids
Branched Chain Amino Acids (22.5g BID)Experimental22.5 grams of BCAA's will be administered twice-daily for 21 days
Receives: Drug: Branched Chain Amino Acids
Branched Chain Amino Acids (15g BID)Experimental15 grams of BCAA's will be administered twice-daily for 21 days
Receives: Drug: Branched Chain Amino Acids
Branched Chain Amino Acids (7.5g BID)Experimental7.5 grams of BCAA's will be administered twice-daily for 21 days
Receives: Drug: Branched Chain Amino Acids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reaction Time Difference Between Drug and Placebo Groups

    Processing speed subtest of the Axon Sports Computerized Cognitive Assessment Tool. The values provided are the median of log reaction time to the processing speed subtest, where a lower score indicates a faster time and thus improved processing speed.

    Measured: Day 21

Secondary outcomes (9)

  1. Clinical Symptoms

    Evaluate whether BCAA supplementation reduces total symptom burden on a total symptom scale of 9 concussion symptoms rated each from 0-6, minimal value 0, maximum value 54, a higher score indicates a higher symptom burden and therefore a worse outcome

    Measured: Day 21

  2. Return to Physical Activity Baseline

    Determine whether BCAA supplementation more rapidly facilitates a return to physical baseline. The physical activity score is scaled on a 6 point Likert scale (0-5), where 0 represents no activity and 5 represents full activity, therefore a higher score represents a closer return to baseline activity by the end of the study period

    Measured: Day 21

  3. Neurocognitive Recovery-- Attention

    Determine whether administration of BCAAs improves the median log reaction time of the attention subtest of the neurocognitive testing battery. A lower median log reaction time represents improved attention

    Measured: Day 21

  4. Compliance and Adherence to Treatment

    Adherence to treatment among dosage groups, reported as the median percent drink consumed among the group across the study period, where 100% = all drink (2 doses per day x 21 days) consumed, and 0% represents no drink consumed

    Measured: Day 21

  5. Tolerability of BCAA's Based on Adverse Events

    Assess the tolerability of BCAA doses based on subject reported adverse events, measured as the percent of participants in each study arm reporting adverse events

    Measured: Day 21

  6. Safety and BCAA Supplementation

    Asses the safety of BCAA doses in concussed athletes through subject reported serious adverse events (SAEs). Reported as the number of participants in each arm experiencing an SAE.

    Measured: Day 21

  7. Neurocognitive Recovery-- Working Memory

    Determine whether administration of BCAAs improves the the median of log reaction time of the working memory subtest of the neurocognitive testing battery. A lower median log reaction time represents improved working memory.

    Measured: Day 21

  8. Neurocognitive Recovery-- Visual Memory

    Determine whether administration of BCAAs improves the accuracy score of the visual memory subtest of the neurocognitive testing battery. A higher accuracy score (scaled 0-1.5) represents improved visual memory

    Measured: Day 21

  9. Return to Baseline Cognitive Activity

    Determine whether BCAA supplementation more rapidly facilitates a return to cognitive activity baseline. The cognitive activity score is scaled on a 5 point Likert scale (0-4), where 0 represents no activity and 4 represents full activity, therefore a higher score represents a closer return to baseline cognitive activity by the end of the study period

    Measured: Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2023
  4. Study completionJan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01860404
Sponsor's protocol ID
13-010227
Acronym
HIT_HEADS
Status last verified
Apr 2024
First submitted
20 May 2013
Last updated
14 May 2024
Data monitoring committee
No

Publications

  • Cole JT, Mitala CM, Kundu S, Verma A, Elkind JA, Nissim I, Cohen AS. Dietary branched chain amino acids ameliorate injury-induced cognitive impairment. Proc Natl Acad Sci U S A. 2010 Jan 5;107(1):366-71. doi: 10.1073/pnas.0910280107. Epub 2009 Dec 7.

    PubMed 19995960

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Branched Chain Amino Acids in people with Brain Concussion, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reaction Time Difference Between Drug and Placebo Groups (time frame: Day 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01860404, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.

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