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Trial record 17 of 2626 for:    brain injury

Association of Amino Acid Prevalence and Chronic Brain Injury

This study has been completed.
Sponsor:
Collaborator:
The Moody Foundation
Information provided by (Responsible Party):
Brent Masel, The Transitional Learning Center, Galveston, TX
ClinicalTrials.gov Identifier:
NCT02113124
First received: April 8, 2014
Last updated: November 17, 2015
Last verified: November 2015
  Purpose
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.

Condition
Chronic Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Association of Amino Acid Prevalence and Chronic Brain Injury

Resource links provided by NLM:


Further study details as provided by The Transitional Learning Center, Galveston, TX:

Primary Outcome Measures:
  • Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating [ Time Frame: Samples collected on day 1 following 8 hour fasting period and again 90 minutes after eating a predetermined meal ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA
Whole blood, oral tissue swab, fecal matter

Enrollment: 43
Study Start Date: December 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Willing to donate 10 ml of blood
  • Willing to donate oral tissue sample
  • Willing to donate fecal sample

Exclusion Criteria:

  • (for brain injured group) have a chronic (greater than two years) traumatic brain injury.
  • Unable to provide to give voluntary informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02113124

Locations
United States, California
Centre for Neuro Skills
Bakersfield, California, United States, 93313
United States, Texas
Centre for Neuro Skills
Dallas, Texas, United States, 75038
Transitional Learning Center
Galveston, Texas, United States, 77550
Sponsors and Collaborators
Brent Masel
The Moody Foundation
Investigators
Principal Investigator: Brent E Masel, MD Transitional Learning Center
  More Information

Responsible Party: Brent Masel, Brent Masel, M.D., The Transitional Learning Center, Galveston, TX
ClinicalTrials.gov Identifier: NCT02113124     History of Changes
Other Study ID Numbers: TLC IRB #200 
Study First Received: April 8, 2014
Results First Received: August 27, 2015
Last Updated: November 17, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by The Transitional Learning Center, Galveston, TX:
Chronic Brain Injury
Traumatic brain injury (TBI)
Amino Acids
Microbiome

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injury, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Damage, Chronic

ClinicalTrials.gov processed this record on December 08, 2016