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Trial record 37 of 157 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND Brain Injuries, Traumatic

Association of Amino Acid Prevalence and Chronic Brain Injury

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ClinicalTrials.gov Identifier: NCT02113124
Recruitment Status : Completed
First Posted : April 14, 2014
Results First Posted : November 17, 2015
Last Update Posted : December 15, 2015
Sponsor:
Collaborator:
The Moody Foundation
Information provided by (Responsible Party):
Brent Masel, The Transitional Learning Center, Galveston, TX

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Cross-Sectional
Condition Chronic Traumatic Brain Injury
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chronic Brain Injury Uninjured Control
Hide Arm/Group Description Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70. This group of individuals have no history of brain injury. Ages range between 35 and 70.
Period Title: Overall Study
Started 18 25
Completed 17 24
Not Completed 1 1
Reason Not Completed
Unable to retrieve blood sample             1             1
Arm/Group Title Chronic Brain Injury Uninjured Control Total
Hide Arm/Group Description Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70. This group of individuals have no history of brain injury. Ages range between 35 and 70. Total of all reporting groups
Overall Number of Baseline Participants 17 24 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 24 participants 41 participants
49  (10) 45  (15) 46  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 24 participants 41 participants
Female
1
   5.9%
7
  29.2%
8
  19.5%
Male
16
  94.1%
17
  70.8%
33
  80.5%
1.Primary Outcome
Title Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating
Hide Description 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.
Time Frame Samples collected on day 1 following 8 hour fasting period and again 90 minutes after eating a predetermined meal
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chronic Brain Injury Uninjured Control
Hide Arm/Group Description:
Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
This group of individuals have no history of brain injury. Ages range between 35 and 70.
Overall Number of Participants Analyzed 17 24
Mean (Standard Error)
Unit of Measure: µM
Branched Chain Amino Acids 487.28  (22.94) 553.70  (38.26)
Essential Amino Acids 1224.19  (27.50) 1339.54  (73.17)
Time Frame Adverse event data were collected on day 1 immediately following each blood draw, for up to 8 hours.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chronic Brain Injury Uninjured Control
Hide Arm/Group Description Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70. This group of individuals have no history of brain injury. Ages range between 35 and 70.
All-Cause Mortality
Chronic Brain Injury Uninjured Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Chronic Brain Injury Uninjured Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chronic Brain Injury Uninjured Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Brent Masel
Organization: The Transitional Learning Center at Galveston
Phone: 409-762-6661 ext 411
EMail: bmasel@tlcgalveston.org
Layout table for additonal information
Responsible Party: Brent Masel, The Transitional Learning Center, Galveston, TX
ClinicalTrials.gov Identifier: NCT02113124     History of Changes
Other Study ID Numbers: TLC IRB #200
First Submitted: April 8, 2014
First Posted: April 14, 2014
Results First Submitted: August 27, 2015
Results First Posted: November 17, 2015
Last Update Posted: December 15, 2015