COMPLETED

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

Conditions

Traumatic Brain Injury TBI sleep cognition bcaa

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Supplementation With Amino Acid Rehabilitative Therapy in TBI (SmART-TBI): A Randomized Placebo-Controlled Trial to Improve Sleep

Quick Facts

Study Start:2021-06-01

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04603443

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Be Veterans (male and female; any race; 18-65 years of age) * Be English speaking * Be accessible via phone * Be non-decisionally impaired * Attest to there being no chance of being or becoming pregnant during the study (if female) * Attest to no history of maple syrup urine disease or known family history of maple urine syrup disease * Have either a history of self-reported sleep disturbances, either as determined via the Insomnia Severity Index, Functional Outcomes of Sleep Questionnaire or Epworth Sleepiness Scale, clinical assessment, and/or a history of self-reported cognitive disturbance (e.g., poor memory, concentration, attention) * Not have an allergy to sucralose * Not be a shift worker (e.g. have worked night or rotating shifts more than twice in the past month) * Not have a diagnosis of amyotrophic lateral sclerosis * Not be currently supplementing their diet with branched chain amino acids * 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 * if already engaged in another sleep intervention, this must be stable and not undergo further changes during the study * Meet diagnostic criteria for TBI using a validated clinical interview	* Pregnancy or female trying to conceive * Under 18 years old * Known history of maple syrup urine disease * Dementia

Inclusion Criteria

Exclusion Criteria

* Be Veterans (male and female; any race; 18-65 years of age)
* Be English speaking
* Be accessible via phone
* Be non-decisionally impaired
* Attest to there being no chance of being or becoming pregnant during the study (if female)
* Attest to no history of maple syrup urine disease or known family history of maple urine syrup disease
* Have either a history of self-reported sleep disturbances, either as determined via the Insomnia Severity Index, Functional Outcomes of Sleep Questionnaire or Epworth Sleepiness Scale, clinical assessment, and/or a history of self-reported cognitive disturbance (e.g., poor memory, concentration, attention)
* Not have an allergy to sucralose
* Not be a shift worker (e.g. have worked night or rotating shifts more than twice in the past month)
* Not have a diagnosis of amyotrophic lateral sclerosis
* Not be currently supplementing their diet with branched chain amino acids
* 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
* if already engaged in another sleep intervention, this must be stable and not undergo further changes during the study
* Meet diagnostic criteria for TBI using a validated clinical interview

* Pregnancy or female trying to conceive
* Under 18 years old
* Known history of maple syrup urine disease
* Dementia

Contacts and Locations

Principal Investigator

Miranda M Lim, MD PhD

PRINCIPAL_INVESTIGATOR

VA Portland Health Care System, Portland, OR

Study Locations (Sites)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-01

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2021-06-01

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

TBI
sleep
cognition
bcaa

Additional Relevant MeSH Terms

Traumatic Brain Injury