Genome-Wide Assocation Study in Patients With Brain Injury Associated Fatigue and Altered Cognition (BIAFAC)
Machine Learning Tools to Identify and Associate Genetic Variants in Patients With Phenotypic Traits of Brain Injury Associated Fatigue and Altered Cognition (BIAFAC)
1 other identifier
observational
68
1 country
1
Brief Summary
The aim of this study is elucidate genetic susceptibility of patients with traumatic brain injury (TBI) and symptoms of Brain Injury Associated Fatigue and Altered Cognition (BIAFAC) using genome-wide association study (GWAS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2020
CompletedFirst Posted
Study publicly available on registry
September 14, 2020
CompletedStudy Start
First participant enrolled
June 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2024
CompletedDecember 24, 2025
December 1, 2025
2.6 years
September 8, 2020
December 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Finding of single nucleotide polymorphisms (SNPs) associated with the traumatic brain injury BIAFAC [ Time Frame: Baseline ]
To identify SNPs related to TBI with BIAFAC using logistic regression after controlling for confounders (GWAS statistical significance threshold, P \< 5.00\*E-08)
Baseline
Study Arms (1)
TBI BIAFAC
100 TBI subjects with BIAFAC will be enrolled. No intervention
Eligibility Criteria
Subjects with a history of TBI and BIAFAC symptoms.
You may qualify if:
- History of TBI
- History of BIAFAC symptoms
- Ages 18 to 70 years
You may not qualify if:
- \. Unable or unwilling to give written consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Biospecimen
Saliva and Blood will have DNA extracted for genotyping
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Randall J Urban, MD
University of Texas
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2020
First Posted
September 14, 2020
Study Start
June 21, 2021
Primary Completion
January 18, 2024
Study Completion
January 18, 2024
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share