What side effects are associated with this type of intervention?

Common treatments for Traumatic Brain Injury (TBI) include medications such as diuretics, anti-seizure drugs, and coma-inducing drugs, as well as rehabilitation therapies. Side effects of these treatments can range from dizziness, fatigue, and electrolyte imbalances to more severe effects like increased risk of infections and cognitive impairments. Specifically, for treatments like Branched Chain Amino Acids (BCAA) supplementation aimed at restoring glutamate neurotransmitter balance, potential side effects may include gastrointestinal discomfort, altered blood sugar levels, and potential interactions with other medications. It is important for patients to discuss these potential side effects with their healthcare provider to tailor the treatment plan to their individual needs.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Traumatic Brain Injury (TBI) that focus on restoring glutamate neurotransmitter balance similar to the Branched Chain Amino Acids (BCAA) being studied. Current treatments for TBI primarily involve supportive care and symptom management rather than targeted pharmacological interventions. Research is ongoing to explore novel therapies, including the use of BCAAs, to address the underlying neurochemical imbalances associated with TBI.

What other types of research exist?

Promising novel alternatives to BCAA for TBI patients include: 1) Memantine, which has shown potential in improving cognitive function in chronic poststroke aphasia and may have similar benefits in TBI. 2) Donepezil and Galantamine, both of which are cholinesterase inhibitors that have demonstrated efficacy in improving cognitive function in poststroke aphasia and could be beneficial for TBI patients. 3) Nutritional supplements such as Coenzyme Q10 and antioxidants, which have been studied for their neuroprotective effects and potential to improve cognitive outcomes in neurodevelopmental disorders and Down syndrome. These alternatives should be discussed with a healthcare provider to determine the most appropriate treatment plan.

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Amino Acid Therapy

BCAA Supplementation for TBI (SmART-TBI Trial)

N/A

Recruiting

Led By Miranda M Lim, MD PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not be starting another sleep intervention (e.g., positive airway pressure therapy for sleep apnea, sedative-hypnotic medication, or cognitive behavioral therapy for insomnia) during the study

Be non-decisionally impaired

Must not have

Under 18 years old

Known history of maple syrup urine disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 4

Summary

This trial tests a dietary supplement called BCAA to help Veterans with mild traumatic brain injury improve their sleep and cognitive function. BCAA helps balance a brain chemical important for these functions. The study aims to see if BCAA is effective and safe over time. BCAA supplementation has shown promise in improving outcomes for severe TBI, but its benefits for mild TBI are not yet well-established.

Who is the study for?

This trial is for English-speaking Veterans aged 18-65 with mild traumatic brain injury (mTBI) who experience sleep disturbances or cognitive issues. Participants must not be pregnant, have maple syrup urine disease, work night shifts, start other sleep treatments during the study, or currently use branched chain amino acids.

What is being tested?

The SmART-TBI trial tests if dietary supplements with Branched Chain Amino Acids can improve sleep and cognition in mTBI patients. It's a controlled study where some get BCAAs and others a protein control to see which helps more.

What are the potential side effects?

Potential side effects are not detailed in the provided information but could include reactions related to amino acid imbalance since BCAAs affect neurotransmitter levels which influence sleep and memory.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not starting any new sleep treatments during the study.

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I am capable of making my own health decisions.

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I confirm I cannot become pregnant during the study.

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I don't have, nor does my family have a history of maple syrup urine disease.

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I do not have amyotrophic lateral sclerosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Select...

I have been diagnosed with maple syrup urine disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Actiwatch Adherence

Change in Monitoring of Side Effects Scale (MOSES)

Change in Reasons for non-adherence

+15 more

Side effects data

From 2023 Phase 2 trial • 42 Patients • NCT01860404

38%

Mild (not interfering with daily life) or Moderate (limitation to daily activity)

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Branched Chain Amino Acids (7.5g BID)

Branched Chain Amino Acids (15g BID)

Branched Chain Amino Acids (22.5g BID)

Branched Chain Amino Acids (27g BID)

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: BCAA 60g/dailyExperimental Treatment1 Intervention

Branched Chain Amino Acids, 30g BID x 12 weeks

Group II: BCAA 40g/dailyExperimental Treatment1 Intervention

Branched Chain Amino Acids, 20g BID x 12 weeks

Group III: BCAA 20g/dailyExperimental Treatment1 Intervention

Branched Chain Amino Acids, 10g BID x 12 weeks

Group IV: Placebo 20g/dailyPlacebo Group1 Intervention

Protein without BCAA, 10g BID x 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Branched Chain Amino Acids

2019

Completed Phase 2

~60

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Traumatic Brain Injury (TBI) often target the regulation of neurotransmitters, particularly glutamate, to prevent excitotoxicity—a condition where excessive glutamate causes neuronal damage. Branched Chain Amino Acids (BCAAs) are being studied for their potential to restore glutamate balance, thereby improving cognitive function and sleep. Arginine-rich peptides and lactate have also shown neuroprotective effects by supporting cerebral blood flow and reducing excitotoxicity. These treatments are crucial for TBI patients as they aim to protect neurons, enhance recovery, and improve overall neurological outcomes.

Transplantation of NSCs Promotes the Recovery of Cognitive Functions by Regulating Neurotransmitters in Rats with Traumatic Brain Injury.Peptide Pharmacological Approaches to Treating Traumatic Brain Injury: a Case for Arginine-Rich Peptides.The neuroprotective effect of lactate is not due to improved glutamate uptake after controlled cortical impact in rats.