BCAAs for Concussion

Overseen By Olivia Podolak

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

Trial Summary

What is the purpose of this trial?

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.

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 it safe to use BCAAs for treating concussions?

There is currently no specific safety data available for using BCAAs (branched-chain amino acids) in treating concussions, but ongoing human trials may soon provide more information. Generally, BCAAs are considered safe for human consumption in other contexts, but it's important to consult with a healthcare provider before starting any new supplement, especially for concussion treatment. ^{1 2 3 4 5}

How does the treatment BCAA differ from other treatments for concussion?

BCAAs (branched-chain amino acids) are unique because they are thought to be neuroprotective and may help improve recovery after a brain injury by supporting brain function and reducing damage. Unlike other treatments, BCAAs are being studied for their potential to be taken before or after a concussion to enhance recovery, which is not a common approach with other treatments. ^{5 6 7 8 9}

Research Team

Daniel Corwin, MD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The potential for DHA to mitigate mild traumatic brain injury. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial of Docosahexaenoic Acid for the Treatment of Sport-Related Concussion in Adolescents. [2022]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Zurich to Berlin-"Where" Are We Now with the Concussion in Sport Group? [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Nutritional Supplements for the Treatment and Prevention of Sports-Related Concussion-Evidence Still Lacking. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of valine, leucine, isoleucine, and a balanced amino acid solution on the seizure threshold to picrotoxin in rats. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Double-blind crossover study of branched-chain amino acid therapy in patients with spinocerebellar degeneration. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Use of graded exercise testing in concussion and return-to-activity management. [2022]

9. United States 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. [2022]