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SmART-TBI: Supplementation With Amino Acid Rehabilitative Therapy in TBI

NCT04603443 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-01-06

No results posted yet for this study

Summary

The most persistent and disabling postconcussive symptoms following mild traumatic brain injury (mTBI) are sleep disturbances and cognitive dysfunction, with few tractable interventions currently available. Here, a novel therapy will be tested consisting of dietary supplementation with branched chain amino acids (BCAA), based on the study team's previous preclinical work showing restoration of glutamate neurotransmitter balance in sleep and memory circuits. Supplementation with Amino acid Rehabilitative Therapy in TBI (SmART-TBI) is a randomized, placebo-controlled, double-blinded, exploratory clinical trial of BCAA intended to establish the feasibility, acceptability, and limited efficacy of long-term BCAA to improve sleep and cognition in Veterans with mTBI. These results will inform the optimal study design of a future, full-scale randomized controlled trial, including the identification of the proper dose and duration of BCAA to improve sleep and the potential subpopulations of Veterans with mTBI that may benefit the most.

Conditions

Interventions

DIETARY_SUPPLEMENT

Branched Chain Amino Acids

Isoleucine, Leucine, and Valine, 10g BID x 12 weeks

DIETARY_SUPPLEMENT

Branched Chain Amino Acids

Isoleucine, Leucine, and Valine, 20g BID x 12 weeks

DIETARY_SUPPLEMENT

Branched Chain Amino Acids

Isoleucine, Leucine, and Valine, 30g BID x 12 weeks

DIETARY_SUPPLEMENT

Protein Control

Protein placebo control - all amino acids except for BCAA, 10g BID x 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Miranda M Lim, MD PhD · VA Portland Health Care System, Portland, OR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04603443 on ClinicalTrials.gov