Traumatic Brain Injury Clinical Trial
— SmART-TBIOfficial title:
Supplementation With Amino Acid Rehabilitative Therapy in TBI (SmART-TBI): A Randomized Placebo-Controlled Trial to Improve Sleep
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion 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 Exclusion Criteria: - Pregnancy or female trying to conceive - Under 18 years old - Known history of maple syrup urine disease - Dementia |
Country | Name | City | State |
---|---|---|---|
United States | VA Portland Health Care System, Portland, OR | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Children's Hospital of Philadelphia, Oregon Health and Science University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Actiwatch Adherence | Proportion of days with actiwatch worn (goal >70% days) | Year 1 | |
Primary | Study Drug Adherence by drug accounting | Proportion of study drug consumed within each timepoint assessed by drug accounting. | Year 1 | |
Primary | Study drug adherence by sleep diary | Proportion of study drug consumed assessed by sleep diary. | Year 1 | |
Primary | Change in Monitoring of Side Effects Scale (MOSES) | Change in Monitoring of side effects scale with emphasis on GI, neurological, psychiatric side effects. Range= 0-124, higher= more side effects. | 12 weeks | |
Primary | Study Drug Adherence by serum or sweat assay | Proportion of study drug consumed assessed by serum or sweat assays of BCAA (goal >70% and >20% increase in levels. | Year 1 | |
Primary | Patient satisfaction with overall study process | Likert scale (1-5, higher= more satisfied) assessing satisfaction with consent process, staff, medication dispensing and regimen, devices/equipment, sleep study, questionnaires, cognitive testing, and overall experience of the study. | 12 weeks | |
Primary | Monitoring of Side Effects Scale (MOSES) | Monitoring of side effects scale with emphasis on GI, neurological, psychiatric side effects. Range= 0-124, higher= more side effects. | 4 weeks | |
Primary | Change in Monitoring of Side Effects Scale (MOSES) | Change in Monitoring of side effects scale with emphasis on GI, neurological, psychiatric side effects. Range= 0-124, higher= more side effects. | 8 weeks | |
Primary | Reasons for non-adherence | Likert scale questions assessing response to statements including: "It upset my stomach", "I didn't have time", "it was too much to drink", "I didn't like the taste", "I didn't feel a benefit". Scale= 0-25, higher=agree more with statement. | 4 weeks | |
Primary | Change in Reasons for non-adherence | Change in Likert scale questions assessing response to statements including: "It upset my stomach", "I didn't have time", "it was too much to drink", "I didn't like the taste", "I didn't feel a benefit". Scale= 0-25, higher=agree more with statement. | 8 weeks | |
Primary | Change in Reasons for non-adherence | Change in Likert scale questions assessing response to statements including: "It upset my stomach", "I didn't have time", "it was too much to drink", "I didn't like the taste", "I didn't feel a benefit". Scale= 0-25, higher=agree more with statement. | 12 weeks | |
Primary | Recruitment | Number of subjects consented of those eligible as descriptive percent | Year 1 | |
Primary | Recruitment source | Proportion of subjects recruited from various sources (clinical referral, flyers, ads, etc) | Year 1 | |
Primary | Retention | Number of completers out of the total number consented as descriptive statistic | Year 1 | |
Primary | Retention by arm | Proportion of drop out within each arm | Year 1 | |
Primary | Incidence of non-participation | Reasons for not participating after initial contact and before consent as descriptive percent. | Year 1 | |
Primary | Screen Failures | Number of subjects enrolled who were later found ineligible as a descriptive percent | Year 1 | |
Primary | Screen Failures | Number of subjects enrolled who were later found ineligible as a descriptive percent | Year 2 | |
Primary | Screen Failures | Number of subjects enrolled who were later found ineligible as a descriptive percent | Year 3 | |
Primary | Screen Failures | Number of subjects enrolled who were later found ineligible as a descriptive percent | Year 4 | |
Primary | Incidence of non-participation | Reasons for not participating after initial contact and before consent as descriptive percent. | Year 2 | |
Primary | Incidence of non-participation | Reasons for not participating after initial contact and before consent as descriptive percent. | Year 3 | |
Primary | Incidence of non-participation | Reasons for not participating after initial contact and before consent as descriptive percent. | Year 4 | |
Primary | Retention by arm | Proportion of drop out within each arm | Year 2 | |
Primary | Retention by arm | Proportion of drop out within each arm | Year 3 | |
Primary | Retention by arm | Proportion of drop out within each arm | Year 4 | |
Primary | Retention | Number of completers out of the total number consented as descriptive statistic | Year 2 | |
Primary | Retention | Number of completers out of the total number consented as descriptive statistic | Year 3 | |
Primary | Retention | Number of completers out of the total number consented as descriptive statistic | Year 4 | |
Primary | Recruitment source | Proportion of subjects recruited from various sources (clinical referral, flyers, ads, etc) | Year 2 | |
Primary | Recruitment source | Proportion of subjects recruited from various sources (clinical referral, flyers, ads, etc) | Year 3 | |
Primary | Recruitment source | Proportion of subjects recruited from various sources (clinical referral, flyers, ads, etc) | Year 4 | |
Primary | Recruitment | Number of subjects consented of those eligible as descriptive percent | Year 2 | |
Primary | Recruitment | Number of subjects consented of those eligible as descriptive percent | Year 3 | |
Primary | Recruitment | Number of subjects consented of those eligible as descriptive percent | Year 4 | |
Primary | Study Drug Adherence by serum or sweat assay | Proportion of study drug consumed assessed by serum or sweat assays of BCAA (goal >70% and >20% increase in levels. | Year 2 | |
Primary | Study drug adherence by serum or sweat assay | Proportion of study drug consumed assessed by serum or sweat assays of BCAA (goal >70% and >20% increase in levels. | Year 3 | |
Primary | Study drug adherence by serum or sweat assay | Proportion of study drug consumed assessed by serum or sweat assays of BCAA (goal >70% and >20% increase in levels. | Year 4 | |
Primary | Study Drug Adherence by sleep diary | Proportion of study drug consumed assessed by sleep diary. | Year 2 | |
Primary | Study Drug Adherence by sleep diary | Proportion of study drug consumed assessed by sleep diary. | Year 3 | |
Primary | Study Drug Adherence by sleep diary | Proportion of study drug consumed assessed by sleep diary. | Year 4 | |
Primary | Study drug adherence by drug accounting | Proportion of study drug consumed within each timepoint assessed by drug accounting. | Year 2 | |
Primary | Study drug adherence by drug accounting | Proportion of study drug consumed within each timepoint assessed by drug accounting. | Year 3 | |
Primary | Study drug adherence by drug accounting | Proportion of study drug consumed within each timepoint assessed by drug accounting. | Year 4 | |
Primary | Actiwatch Adherence | Proportion of days with actiwatch worn (goal >70% days) | Year 2 | |
Primary | Actiwatch Adherence | Proportion of days with actiwatch worn (goal >70% days) | Year 3 | |
Primary | Actiwatch Adherence | Proportion of days with actiwatch worn (goal >70% days) | Year 4 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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