Association of Amino Acid Prevalence and Chronic Brain Injury

NCT02113124 | Completed Results

• 1 other identifier: TLC IRB #200
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Chronic Traumatic Brain Injury

Keywords

Chronic Brain Injury; Traumatic brain injury (TBI); Amino Acids; Microbiome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• (for brain injured group) have a chronic (greater than two years) traumatic brain injury.
• Unable to provide to give voluntary informed consent

Sponsors & Collaborators

• Brent Masel: lead
• The Moody Foundation: collaborator

Study Sites (3)

Centre for Neuro Skills

Bakersfield, California, 93313, United States

Location

Centre for Neuro Skills

Dallas, Texas, 75038, United States

Location

Transitional Learning Center

Galveston, Texas, 77550, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, oral tissue swab, fecal matter

MeSH Terms

Conditions

Brain Injury, Chronic; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Limitations and Caveats

No limitations reported

Results Point of Contact

• Title: Dr. Brent Masel
• Organization: The Transitional Learning Center at Galveston

bmasel@tlcgalveston.org

409-762-6661

Study Officials

• Brent E Masel, MD

  Transitional Learning Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Brent Masel, M.D.

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 14, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 15, 2015
• Results First Posted: November 17, 2015

Record last verified: 2015-11

Locations

US (3)