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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
Awards & highlights
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 belowSelect...
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
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 moreSide effects data
From 2023 Phase 2 trial • 42 Patients • NCT0186040438%
Mild (not interfering with daily life) or Moderate (limitation to daily activity)
100%
80%
60%
40%
20%
0%
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
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.
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.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
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3,361,270 Total Patients Enrolled
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with traumatic brain injury (TBI) through a reliable interview process.I am between 18 and 65 years old.You have reported having trouble sleeping or difficulty with memory and focus.I am a veteran aged between 18 and 65.I am not starting any new sleep treatments during the study.I can be reached by phone.I am capable of making my own health decisions.I confirm I cannot become pregnant during the study.I don't have, nor does my family have a history of maple syrup urine disease.I am under 18 years old.You have dementia.I have been diagnosed with maple syrup urine disease.You are not allergic to sucralose.You are not currently taking branched chain amino acid supplements.I do not have amyotrophic lateral sclerosis.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo 20g/daily
- Group 2: BCAA 60g/daily
- Group 3: BCAA 40g/daily
- Group 4: BCAA 20g/daily
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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