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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 4
Awards & highlights

SmART-TBI Trial Summary

This trial will test a new therapy consisting of dietary supplementation with branched chain amino acids (BCAA) to see if it can help improve sleep and cognition in Veterans with mTBI.

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.Check my eligibility
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.See study design
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.

SmART-TBI Trial 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.

SmART-TBI Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Actiwatch Adherence
Change in Monitoring of Side Effects Scale (MOSES)
Change in Reasons for non-adherence
+15 more

SmART-TBI 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

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,229 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,581,075 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
7,385,612 Total Patients Enrolled

Media Library

Branched Chain Amino Acids (Amino Acid Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04603443 — N/A
Traumatic Brain Injury Research Study Groups: Placebo 20g/daily, BCAA 60g/daily, BCAA 40g/daily, BCAA 20g/daily
Traumatic Brain Injury Clinical Trial 2023: Branched Chain Amino Acids Highlights & Side Effects. Trial Name: NCT04603443 — N/A
Branched Chain Amino Acids (Amino Acid Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04603443 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment capacity for this experiment?

"Affirmative. Clinicaltrials.gov hosts information which suggests that this trial is currently enrolling participants. It was initially listed on June 1st 2021 and the most recent update took place on May 13th 2022. 200 patients are needed to be enrolled at a single study site."

Answered by AI

Is there still room in this experiment for new participants?

"Clinicaltrials.gov reports that this clinical trial, initially published on June 1st 2021 and last modified on May 13th 2022, is now looking for participants."

Answered by AI

Who else is applying?

What state do they live in?
Oregon
How old are they?
18 - 65
What site did they apply to?
VA Portland Health Care System, Portland, OR
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
SmART-TBI: Supplementation With Amino Acid Rehabilitative Therapy in TBI
2021. "SmART-TBI: Supplementation With Amino Acid Rehabilitative Therapy in TBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04603443.
All > Sleep
~38 spots leftby Dec 2024
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