BCAAs for Concussion

Overseen By Melissa Godfrey, MPH

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Children's Hospital of Philadelphia

Must not be taking: Investigational drugs

Disqualifiers: Moderate/severe TBI, Recent concussion, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether branched chain amino acids (BCAAs) can aid recovery from concussions. Participants will receive a solution containing either BCAAs or a placebo (a lookalike substance with no active ingredients) to determine if BCAAs accelerate recovery. It suits individuals who have had a concussion in the last four days and weigh at least 40 kg. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have used any investigational drugs in the last 30 days, you cannot participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that branched chain amino acids (BCAAs) are generally safe for consumption. An initial study indicated that BCAAs helped individuals recover from concussions without serious side effects. Additional research suggests that BCAAs can protect the brain and aid recovery after injuries such as concussions. Although these early findings are promising and suggest BCAAs are safe, further research is necessary for confirmation. The treatment is currently in a Phase 2 trial, indicating some evidence of safety, but it is still under study to ensure safety for all individuals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for concussions focus on symptom management and rest. But Branched Chain Amino Acids (BCAAs) work differently, targeting the brain's recovery processes directly. Unlike traditional care, BCAAs are thought to help repair brain damage by supporting neurotransmitter production and reducing inflammation. Researchers are excited about BCAAs because they offer a novel way to potentially accelerate healing and improve outcomes for concussion patients, something existing treatments don't specifically address.

What evidence suggests that BCAAs might be an effective treatment for concussion?

Research has shown that branched chain amino acids (BCAAs) might aid recovery from concussions. In one study, teenagers and young adults with concussions who took BCAAs recovered faster than those who did not. Another study found that BCAAs improved thinking skills and reduced problems in individuals with severe brain injuries. Additionally, animal studies have demonstrated that BCAAs can help restore important brain chemicals after an injury. These early findings suggest that BCAAs could be a promising option for concussion recovery. Participants in this trial will receive either a BCAA solution or a placebo to further investigate these potential benefits. ^{1 2 3 4 5}

Who Is on the Research Team?

Daniel Corwin, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for males and females aged 11-23 who've had a concussion within the last 4 days, weigh at least 40kg, meet specific concussion criteria, and can give informed consent. Females post-menarche must test negative for pregnancy and use contraception.

Inclusion Criteria

I am not pregnant and will use birth control.

I meet the concussion criteria set by the American Congress of Rehabilitative Medicine.

I am between 11 and 23 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high-dose BCAAs or placebo to promote concussion recovery

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BCAA

Trial Overview

The study tests if high-dose branched chain amino acids (BCAAs) help with concussion recovery compared to a placebo. Participants are randomly assigned to receive either BCAAs or placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Drug: Branched Chain Amino Acids Experimental Treatment 1 Intervention

The three BCAAs will be combined together and dissolved into a flavored solution.

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Akiva Cohen

Lead Sponsor

Published Research Related to This Trial

Omega-3 fatty acids, particularly docosahexaenoic acid, have shown potential therapeutic effects in various conditions, including concussion management, due to their mechanisms of action that may help address cellular and microstructural damage.

Recent research indicates that concussions can lead to metabolic and mitochondrial dysfunction in the brain, suggesting that omega-3 fatty acids could play a role in supporting recovery from such injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential for DHA to mitigate mild traumatic brain injury. Bailes, JE., Patel, V.[2017]

The Montreal Virtual Exertion (MOVE) protocol is a safe and feasible graded exertion test for both healthy children and those with subacute concussion, as no adverse events were reported during the study.

Increases in heart rate and perceived exertion were similar between the MOVE protocol and the traditional Buffalo Concussion Treadmill Test, suggesting that MOVE can effectively assess exertion levels without the need for expensive equipment or in-person supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An At-Home, Virtually Administered Graded Exertion Protocol for Use in Concussion Management: Preliminary Evaluation of Safety and Feasibility for Determining Clearance to Return to High-Intensity Exercise in Healthy Youth and Children With Subacute Concussion. Teel, E., Alarie, C., Swaine, B., et al.[2023]

In a study involving 50 adult mice, pre-treatment with branched-chain amino acids (BCAAs) before a traumatic brain injury (TBI) significantly improved motor recovery and cognitive function compared to untreated groups.

The best outcomes were observed in mice that received both pre- and post-treatment with BCAAs, suggesting that BCAAs may provide neuroprotective effects and support glutamate balance in the brain after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Branched-Chain Amino Acids Are Neuroprotective Against Traumatic Brain Injury and Enhance Rate of Recovery: Prophylactic Role for Contact Sports and Emergent Use. Dickerman, RD., Williamson, J., Mathew, E., et al.[2022]

The Buffalo Concussion Treadmill Test (BCTT) is a safe and reliable method for diagnosing physiological dysfunction in individuals with concussion and can differentiate it from other conditions like cervical injury.

The BCTT is also effective in quantifying the severity of concussion symptoms and is used to create a safe aerobic exercise program that can help speed up recovery and facilitate a return to normal activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of graded exercise testing in concussion and return-to-activity management. Leddy, JJ., Willer, B.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38468511/

A Pilot Randomized Controlled Trial of the Tolerability, Safety ...

This study provides the first demonstration of efficacy, as well as safety and tolerability, of BCAAs in concussed adolescents and young adults.

2.

chop.edu

chop.edu/news/chop-researchers-find-branched-chain-amino-acid-supplementation-may-aid-concussion-recovery

CHOP Researchers Find Branched Chain Amino Acid ...

Pilot study reveals early evidence of efficacy of a pharmacologic treatment for concussion, as patients experienced faster symptom reduction ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9438436/

Branched-Chain Amino Acids Are Neuroprotective Against ...

Despite clinically significant improvements in severe TBI patients given BCAAs after TBI, the approach is largely an unrecognized option. Further, TBI continues ...

4.

liebertpub.com

liebertpub.com/doi/10.1089/neu.2023.0433

Head Injury Treatment With Healthy and Advanced Dietary ...

BCAA supplementation in this population led to moderate improvement in disability and cognitive function. A single study of 18 patients (primarily adults) with ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01860404

NCT01860404 | BCAA Supplementation for Concussion

When these brain-injured animals received dietary supplementation with BCAA's, the concentrations of these amino acids were restored in the injured hippocampus ...