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| Name | Class |
|---|---|
| The Moody Foundation | OTHER |
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Years after a suffering a brain injury, individuals remain in a physically and cognitively impaired state. The investigators believe that the concentrations of amino acids in the blood are chronically altered and yield negative effects on the individuals health. Preliminary data has shown significantly lower concentrations of amino acids in serum samples from the TBI population, these diminished levels of amino acids may be due to changes in the microbiome. Understanding these changes will help guide rehabilitative services for this population. Individuals with a chronic brain injury will donate samples of blood, oral tissue, and fecal matter to be compared to that of non-injured individuals. Genetic information from the hosts will be striped and discarded; participant's genetic information will not be retained. To better understand changes in the microbiome, any history of antibiotics and probiotics will be assessed.
The purpose of this study is to evaluate the levels of Amino Acids in adult individuals with chronic (> 2 years) traumatic brain injury (TBI) when compared to a non-brain injured cohort population.
Preliminary data from an assay of amino acids in individuals with chronic TBI compared to an assay of individuals without a TBI revealed significantly lower concentrations of amino acids within the TBI group.
The composition and structure of the oral and fecal microbiome will be determined by 16S rDNA sequencing. Taxonomic and community structure profiles will be treated as outcome variables and modeled together with the participant's plasma amino acid concentration, years post-injury, age, sex and other variables to determine correlations. These correlations may improve our understanding of the diminished amino acid metabolism within the chronic TBI population.
The endpoint will identify the microbiome structure and composition by 16S rRNA gene sequencing within the TBI and healthy participants and to assess the participant's amino acid concentrations and other participant demographics and phenotypic characteristics (years post-injury, age, sex). This comparison may improve our understanding of the diminished amino acid metabolism within the chronic TBI population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic brain injury | Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 21 to 70. | ||
| Uninjured control | This group of individuals have no history of brain injury. Ages range between 21 and 70. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating | 5 ml of blood will be acquired following a 8-hour fasting period to determine baseline concentrations of amino acids. A meal will then be provided and another blood sample will be acquired 90 minutes after completing the meal to examine the change in amino acid concentration. These samples will be used to determine the levels of each essential amino acid present. | Samples collected on day 1 following 8 hour fasting period and again 90 minutes after eating a predetermined meal |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals in the chronic brain injured group are recruited from traumatic brain injury rehabilitation facilities. These facilities include Tideway in Galveston, Texas, Centre for Neuro Skills in Bakersfield, CA, and Centre for Neuro Skills in Dallas, TX. The cohorts for this study will be recruited from the communities surrounding the rehabilitation facilities.
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| Name | Affiliation | Role |
|---|---|---|
| Brent E Masel, MD | Transitional Learning Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Neuro Skills | Bakersfield | California | 93313 | United States | ||
| Centre for Neuro Skills |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chronic Brain Injury | Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70. |
| FG001 | Uninjured Control | This group of individuals have no history of brain injury. Ages range between 35 and 70. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chronic Brain Injury | Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70. |
| BG001 | Uninjured Control | This group of individuals have no history of brain injury. Ages range between 35 and 70. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating | 5 ml of blood will be acquired following a 8-hour fasting period to determine baseline concentrations of amino acids. A meal will then be provided and another blood sample will be acquired 90 minutes after completing the meal to examine the change in amino acid concentration. These samples will be used to determine the levels of each essential amino acid present. | Posted | Mean | Standard Error | µM | Samples collected on day 1 following 8 hour fasting period and again 90 minutes after eating a predetermined meal |
|
Adverse event data were collected on day 1 immediately following each blood draw, for up to 8 hours.
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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 | Chronic Brain Injury | Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70. |
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No limitations reported
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brent Masel | The Transitional Learning Center at Galveston | 409-762-6661 | 411 | bmasel@tlcgalveston.org |
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| ID | Term |
|---|---|
| D020208 | Brain Injury, Chronic |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Whole blood, oral tissue swab, fecal matter
| Dallas |
| Texas |
| 75038 |
| United States |
| Transitional Learning Center | Galveston | Texas | 77550 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
This group of individuals have no history of brain injury. Ages range between 35 and 70. |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Uninjured Control | This group of individuals have no history of brain injury. Ages range between 35 and 70. | 0 | 25 | 0 | 25 |
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| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |