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| Name | Class |
|---|---|
| The Dana Foundation | OTHER |
| Main Line Health | OTHER |
| University of Pennsylvania | OTHER |
| Pennsylvania Department of Health |
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This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAA's) in the treatment of concussion. The aim of the study is to determine whether, compared to placebo treatment, administration of BCAA's, at one or more doses, after a concussion improves neurocognitive recovery at one or more time-periods post concussion.
Annually, between 100,000 to 140,000 children present to the emergency department for concussion in the United States.1 The Centers for Disease Control now estimates that 1.6 - 3.8 million sports related concussions occur each year in the United States. A large proportion of these patients have enduring cognitive and neurobehavioral problems. Concussion is a heterogeneous insult to the brain that precipitates a complex pathophysiological process that can result in a cascade of deleterious side effects. At present, there are no proven therapies to mitigate or prevent the neurocognitive and neurobehavioral consequences of concussions. The limbic hippocampus, a brain structure crucial for learning and memory, is often damaged in concussion. In preclinical studies in our laboratory, analysis of ipsilateral hippocampi isolated from mice after traumatic brain injury (TBI) demonstrated that only the concentrations of the three BCAA's (valine, isoleucine, and leucine) were significantly altered (reduced) after injury. When these brain-injured animals received dietary supplementation with BCAA's, the concentrations of these amino acids were restored in the injured hippocampus and the injured animals demonstrated significant cognitive improvement to levels comparable to those obtained in non-injured control animals. In light of these results and the increasing awareness and morbidity associated with concussion, we are proposing a pilot therapeutic exploratory clinical trial to determine the effects of BCAA's in reducing the neurocognitive side effects of concussion injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo will be administered orally twice daily for 21 days |
|
| Branched Chain Amino Acids (27g BID) | Experimental | 27 grams of BCAA's will be administered twice-daily for 21 days |
|
| Branched Chain Amino Acids (22.5g BID) | Experimental | 22.5 grams of BCAA's will be administered twice-daily for 21 days |
|
| Branched Chain Amino Acids (15g BID) | Experimental | 15 grams of BCAA's will be administered twice-daily for 21 days |
|
| Branched Chain Amino Acids (7.5g BID) | Experimental | 7.5 grams of BCAA's will be administered twice-daily for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Branched Chain Amino Acids | Drug | The three BCAA's will be combined together and dissolved in a flavored solution. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reaction Time Difference Between Drug and Placebo Groups | Processing speed subtest of the Axon Sports Computerized Cognitive Assessment Tool. The values provided are the median of log reaction time to the processing speed subtest, where a lower score indicates a faster time and thus improved processing speed. | Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Symptoms | Evaluate whether BCAA supplementation reduces total symptom burden on a total symptom scale of 9 concussion symptoms rated each from 0-6, minimal value 0, maximum value 54, a higher score indicates a higher symptom burden and therefore a worse outcome | Day 21 |
| Return to Physical Activity Baseline |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sage Myers, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19995960 | Background | Cole JT, Mitala CM, Kundu S, Verma A, Elkind JA, Nissim I, Cohen AS. Dietary branched chain amino acids ameliorate injury-induced cognitive impairment. Proc Natl Acad Sci U S A. 2010 Jan 5;107(1):366-71. doi: 10.1073/pnas.0910280107. Epub 2009 Dec 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo will be administered orally twice daily for 21 days Placebo solution: The placebo solution will have similar taste, texture, consistency and appearance as the branched chain amino acid (BCAA) solution. |
| FG001 | Branched Chain Amino Acids (7.5g BID) | 7.5 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAAs will be combined together and dissolved in a flavored solution. |
| FG002 | Branched Chain Amino Acids (15g BID) | 15 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAA's will be combined together and dissolved in a flavored solution. |
| FG003 | Branched Chain Amino Acids (22.5g BID) | 22.5 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAAs will be combined together and dissolved in a flavored solution. |
| FG004 | Branched Chain Amino Acids (27g BID) | 27 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAAs will be combined together and dissolved in a flavored solution. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Includes all 42 patients randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo will be administered orally twice daily for 21 days Placebo solution: The placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution. |
| BG001 | Branched Chain Amino Acids (7.5g BID) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reaction Time Difference Between Drug and Placebo Groups | Processing speed subtest of the Axon Sports Computerized Cognitive Assessment Tool. The values provided are the median of log reaction time to the processing speed subtest, where a lower score indicates a faster time and thus improved processing speed. | Not all participants completed daily neurocognitive testing batteries, therefore there is incompleteness in the Day 21 values. In total, only 13 participants completed neurocognitive testing on day 21 (compared to 28 participants who completed full follow-up) | Posted | Median | Inter-Quartile Range | log(milliseconds) | Day 21 |
|
21 days (duration of study period)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo will be administered orally twice daily for 21 days Placebo solution: The placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild (not interfering with daily life) or Moderate (limitation to daily activity) | Gastrointestinal disorders | Non-systematic Assessment |
There are several key limitations to our study that necessitate a larger, more definitive trial. Due to a combination of initially more strict inclusion criteria, and the impact of the coronavirus pandemic, our sample size was smaller than anticipated. This, combined with poorer than expected follow-up, led us to have to use alternative statistical analytic methods. We were further limited by missing data. This also necessitated the alternative analytic approach / post-hoc analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Corwin | Children's Hospital of Philadelphia | 215-327-2306 | corwind@chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2019 | Jan 26, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 21, 2020 | Jan 26, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000596 | Amino Acids |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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| OTHER_GOV |
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| Placebo solution | Drug | The placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution. |
|
Determine whether BCAA supplementation more rapidly facilitates a return to physical baseline. The physical activity score is scaled on a 6 point Likert scale (0-5), where 0 represents no activity and 5 represents full activity, therefore a higher score represents a closer return to baseline activity by the end of the study period |
| Day 21 |
| Neurocognitive Recovery-- Attention | Determine whether administration of BCAAs improves the median log reaction time of the attention subtest of the neurocognitive testing battery. A lower median log reaction time represents improved attention | Day 21 |
| Compliance and Adherence to Treatment | Adherence to treatment among dosage groups, reported as the median percent drink consumed among the group across the study period, where 100% = all drink (2 doses per day x 21 days) consumed, and 0% represents no drink consumed | Day 21 |
| Tolerability of BCAA's Based on Adverse Events | Assess the tolerability of BCAA doses based on subject reported adverse events, measured as the percent of participants in each study arm reporting adverse events | Day 21 |
| Safety and BCAA Supplementation | Asses the safety of BCAA doses in concussed athletes through subject reported serious adverse events (SAEs). Reported as the number of participants in each arm experiencing an SAE. | Day 21 |
| Neurocognitive Recovery-- Working Memory | Determine whether administration of BCAAs improves the the median of log reaction time of the working memory subtest of the neurocognitive testing battery. A lower median log reaction time represents improved working memory. | Day 21 |
| Neurocognitive Recovery-- Visual Memory | Determine whether administration of BCAAs improves the accuracy score of the visual memory subtest of the neurocognitive testing battery. A higher accuracy score (scaled 0-1.5) represents improved visual memory | Day 21 |
| Return to Baseline Cognitive Activity | Determine whether BCAA supplementation more rapidly facilitates a return to cognitive activity baseline. The cognitive activity score is scaled on a 5 point Likert scale (0-4), where 0 represents no activity and 4 represents full activity, therefore a higher score represents a closer return to baseline cognitive activity by the end of the study period | Day 21 |
| Withdrawal by Subject |
|
7.5 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAA's will be combined together and dissolved in a flavored solution. |
| BG002 | Branched Chain Amino Acids (15g BID) | 15 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAA's will be combined together and dissolved in a flavored solution. |
| BG003 | Branched Chain Amino Acids (22.5g BID) | 22.5 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAA's will be combined together and dissolved in a flavored solution. |
| BG004 | Branched Chain Amino Acids (27g BID) | 27 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAA's will be combined together and dissolved in a flavored solution. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Days from injury to enrollment | Median | Inter-Quartile Range | days |
|
| OG001 | Branched Chain Amino Acids (7.5g BID) | 7.5 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAAs will be combined together and dissolved in a flavored solution. |
| OG002 | Branched Chain Amino Acids (15g BID) | 15 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAAs will be combined together and dissolved in a flavored solution. |
| OG003 | Branched Chain Amino Acids (22.5g BID) | 22.5 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAAs will be combined together and dissolved in a flavored solution. |
| OG004 | Branched Chain Amino Acids (27g BID) | 27 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAAs will be combined together and dissolved in a flavored solution. |
|
|
|
| Secondary | Clinical Symptoms | Evaluate whether BCAA supplementation reduces total symptom burden on a total symptom scale of 9 concussion symptoms rated each from 0-6, minimal value 0, maximum value 54, a higher score indicates a higher symptom burden and therefore a worse outcome | Only 20 of 38 subjects completed daily symptom and activity logs though the 3 weeks of the study | Posted | Median | Inter-Quartile Range | units on a scale | Day 21 |
|
|
|
|
| Secondary | Return to Physical Activity Baseline | Determine whether BCAA supplementation more rapidly facilitates a return to physical baseline. The physical activity score is scaled on a 6 point Likert scale (0-5), where 0 represents no activity and 5 represents full activity, therefore a higher score represents a closer return to baseline activity by the end of the study period | Only 20 of 38 subjects completed daily symptom and activity logs though the 3 weeks of the study | Posted | Median | Inter-Quartile Range | score on a scale | Day 21 |
|
|
|
|
| Secondary | Neurocognitive Recovery-- Attention | Determine whether administration of BCAAs improves the median log reaction time of the attention subtest of the neurocognitive testing battery. A lower median log reaction time represents improved attention | Not all participants completed daily neurocognitive testing batteries, therefore there is incompleteness in the Day 21 values. In total, only 13 participants completed neurocognitive testing on day 21 (compared to 28 participants who completed full follow-up) | Posted | Median | Inter-Quartile Range | log(milliseconds) | Day 21 |
|
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|
|
| Secondary | Compliance and Adherence to Treatment | Adherence to treatment among dosage groups, reported as the median percent drink consumed among the group across the study period, where 100% = all drink (2 doses per day x 21 days) consumed, and 0% represents no drink consumed | All 38 participants, minus the 4 who withdrew following randomization, are included in the adherence measure | Posted | Median | Inter-Quartile Range | Percent of total drink consumed | Day 21 |
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| Secondary | Tolerability of BCAA's Based on Adverse Events | Assess the tolerability of BCAA doses based on subject reported adverse events, measured as the percent of participants in each study arm reporting adverse events | Adverse events were only evaluated for the 38 subjects who participated. The 4 subjects who withdrew did so prior to receiving any study medication. | Posted | Count of Participants | Participants | Day 21 |
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| Secondary | Safety and BCAA Supplementation | Asses the safety of BCAA doses in concussed athletes through subject reported serious adverse events (SAEs). Reported as the number of participants in each arm experiencing an SAE. | Only the 38 participants who received any study drug are included. The 4 who withdrew did so immediately after randomization before consuming any product. | Posted | Count of Participants | Participants | Day 21 |
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| Secondary | Neurocognitive Recovery-- Working Memory | Determine whether administration of BCAAs improves the the median of log reaction time of the working memory subtest of the neurocognitive testing battery. A lower median log reaction time represents improved working memory. | Not all participants completed daily neurocognitive testing batteries, therefore there is incompleteness in the Day 21 values. In total, only 13 participants completed neurocognitive testing on day 21 (compared to 28 participants who completed full follow-up) | Posted | Median | Inter-Quartile Range | log(milliseconds) | Day 21 |
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| Secondary | Neurocognitive Recovery-- Visual Memory | Determine whether administration of BCAAs improves the accuracy score of the visual memory subtest of the neurocognitive testing battery. A higher accuracy score (scaled 0-1.5) represents improved visual memory | Not all participants completed daily neurocognitive testing batteries, therefore there is incompleteness in the Day 21 values. In total, only 13 participants completed neurocognitive testing on day 21 (compared to 28 participants who completed full follow-up) | Posted | Median | Inter-Quartile Range | score on a scale | Day 21 |
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| Secondary | Return to Baseline Cognitive Activity | Determine whether BCAA supplementation more rapidly facilitates a return to cognitive activity baseline. The cognitive activity score is scaled on a 5 point Likert scale (0-4), where 0 represents no activity and 4 represents full activity, therefore a higher score represents a closer return to baseline cognitive activity by the end of the study period | Only 20 of 38 subjects completed daily symptom and activity logs though the 3 weeks of the study | Posted | Median | Inter-Quartile Range | score on a scale | Day 21 |
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| Post-Hoc | Regression Model Processing Speed Change | Change in log reaction time of the neurocognitive testing processing speed score for increase of total study dose of 500 g in adjusted regression. This represents a change in the log reaction time for, on average, each increase of 500 g of study drug consumed between baseline and end of study period (between baseline, day 0, and day 21). A lower reaction time (on a scale of 2.35 to 2.80) indicates faster speed and thus improved neurocognitive function. The least squares mean for the model for each 500 g of drug consumed, with the standard error, are presented, as is the p-value for the slope parameter of the regression. | 18 out of 38 participants completed at least 7 measurements of neurocognitive testing to contribute to the overall regression analysis. Participants across all treatment arms were combined for this regression as it was, rather than in intention-to-treat analysis, a dose response analysis testing the effect of actual study drug consumed | Posted | Least Squares Mean | Standard Error | log(milliseconds) | Baseline and 21 days |
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| Post-Hoc | Regression Model Attention Change | Change in log reaction time of the neurocognitive testing attention score for increase of total study dose of 500 g in adjusted regression. This represents a change in the log reaction time for, on average, each increase of 500 g of study drug consumed between baseline and end of study period (between baseline, day 0, and day 21). A lower reaction time (on a scale of 2.35 to 2.80) indicates faster speed and thus improved neurocognitive function. The least squares mean for the model for each 500 g of drug consumed, with the standard error, are presented, as is the p-value for the slope parameter of the regression. | 18 out of 38 participants completed at least 7 measurements of neurocognitive testing to contribute to the overall regression analysis. Participants across all treatment arms were combined for this regression as it was, rather than in intention-to-treat analysis, a dose response analysis testing the effect of actual study drug consumed | Posted | Least Squares Mean | Standard Error | log(milliseconds) | Baseline and 21 days |
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| Post-Hoc | Regression Model Working Memory Change | Change in log reaction time of the neurocognitive testing working memory score for increase of total study dose of 500 g in adjusted regression. This represents a change in the log reaction time for, on average, each increase of 500 g of study drug consumed between baseline and end of study period (between baseline, day 0, and day 21). A lower reaction time (on a scale of 2.35 to 2.80) indicates faster speed and thus improved neurocognitive function. The least squares mean for the model for each 500 g of drug consumed, with the standard error, are presented, as is the p-value for the slope parameter of the regression. | contribute to the overall regression analysis. Participants across all treatment arms were combined for this regression as it was, rather than in intention-to-treat analysis, a dose response analysis testing the effect of actual study drug consumed | Posted | Least Squares Mean | Standard Error | log(milliseconds) | Baseline and 21 days |
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| Post-Hoc | Regression Mode Visual Learning Change | Change in accuracy score of the neurocognitive testing processing speed score for increase of total study dose of 500 g in adjusted regression. This represents a change in the accuracy score for, on average, each increase of 500 g of study drug consumed between baseline and end of study period (between baseline, day 0, and day 21). The accuracy scale score is scaled from 0 to 1.5, and a higher score indicates higher accuracy and thus higher neurocognitive function. The least squares mean for the model for each 500 g of drug consumed, with the standard error, are presented, as is the p-value for the slope parameter of the regression. | contribute to the overall regression analysis. Participants across all treatment arms were combined for this regression as it was, rather than in intention-to-treat analysis, a dose response analysis testing the effect of actual study drug consumed | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 21 days |
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| Post-Hoc | Total Symptom Score Change | Change in total symptom score for increase of total study dose of 500 g in adjusted regression. This represents a change in the total symptom score for, on average, each increase of 500 g of study drug consumed between baseline and end of study period (between baseline, day 0, and day 21). The symptom score is scaled from 0-54, with a higher number representing a higher symptom burden and thus a worse outcome. The least squares mean for the model for each 500 g of drug consumed, with the standard error, are presented, as is the p-value for the slope parameter of the regression. | 26 out of 38 participants completed at least 7 measurements of the daily symptom and activity questionnaire to contribute to the overall regression analysis. Participants across all treatment arms were combined for this regression as it was, rather than in intention-to-treat analysis, a dose response analysis testing the effect of actual study drug consumed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 21 days |
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| Post-Hoc | Physical Activity Score Change | Change in physical activity score for increase of total study dose of 500 g in adjusted regression. This represents a change in the physical activity score for, on average, each increase of 500 g of study drug consumed between baseline and end of study period (between baseline, day 0, and day 21). The physical activity scale is 0-5, with a maximum score of 5 representing full baseline physical activity. The least squares mean for the model for each 500 g of drug consumed, with the standard error, are presented, as is the p-value for the slope parameter of the regression. | 26 out of 38 participants completed at least 7 measurements of the daily symptom and activity questionnaire to contribute to the overall regression analysis. Participants across all treatment arms were combined for this regression as it was, rather than in intention-to-treat analysis, a dose response analysis testing the effect of actual study drug consumed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 21 days |
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| Post-Hoc | Regression Model Cognitive Activity Score Change | Change in cognitive activity score for increase of total study dose of 500 g in adjusted regression. This represents a change in the cognitive activity score for, on average, each increase of 500 g of study drug consumed between baseline and end of study period (between baseline, day 0, and day 21). The cognitive activity scale is 0-4, with a maximum score of 4 representing full cognitive baseline activity. The least squares mean for the model for each 500 g of drug consumed, with the standard error, are presented, as is the p-value for the slope parameter of the regression. | 26 out of 38 participants completed at least 7 measurements of the daily symptom and activity questionnaire to contribute to the overall regression analysis. Participants across all treatment arms were combined for this regression as it was, rather than in intention-to-treat analysis, a dose response analysis testing the effect of actual study drug consumed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 21 days |
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| 0 |
| 8 |
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | Branched Chain Amino Acids (7.5g BID) | 7.5 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAAs will be combined together and dissolved in a flavored solution. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG002 | Branched Chain Amino Acids (15g BID) | 15 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAAs will be combined together and dissolved in a flavored solution. | 0 | 9 | 0 | 9 | 1 | 9 |
| EG003 | Branched Chain Amino Acids (22.5g BID) | 22.5 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAAs will be combined together and dissolved in a flavored solution. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG004 | Branched Chain Amino Acids (27g BID) | 27 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAAs will be combined together and dissolved in a flavored solution. | 0 | 8 | 0 | 8 | 1 | 8 |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |