Acute & Mild TBI Injury in Military & Civilian Population Using Advanced

Status Active, not recruiting

Clinical Trial Summary

This is a prospective longitudinal study of patients with acute mTBI and comparison with chronic mTBI patients and a cohort without history of TBI or none within 5 years of enrollment. The patients will be recruited from the eligible population at military medical centers in the National Capital Region.

Clinical Trial Description

All patients seen with suspected mTBI will undergo standard TBI assessment per institutional standard operating procedure. Mild TBI will be defined by Department of Defense/Department of Veterans Affairs Consensus- based Classification of Closed TBI Severity. This project will leverage several existing TBI clinics/programs and benefits from the clinical and technical knowledge gained from each. All participants will undergo the same screening, eligibility assessment, informed consent, baseline history/physical, statement of negative pregnancy status (if applicable), survey questionnaires, VOMS, BESS, King-Devick and abbreviated neurocognitive testing once. Participants will undergo research MRI twice at time points > 2 weeks apart and one clinical MRI. Blood samples will be collected at each study visit. The research blood specimens will be processed immediately, frozen and sent to the WRNMMC Research Laboratory for future biomarker and genomic analysis. MRI imaging findings (common data elements or newer imaging biomarkers discovered during the initial two-year technical development phase) will be analyzed to determine the most relevant biomarkers indicative of mTBI injury and/or prognosis for recovery. More advanced correlation analysis and relative risk regression will be performed to correlate mTBI and PTSD and their comorbid associations (e.g., depression, anxiety), Statistical tests will be corrected for multiple comparisons as appropriate. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05101239
Study type	Observational [Patient Registry]
Source	The Geneva Foundation
Contact
Status	Active, not recruiting
Phase
Start date	November 8, 2019
Completion date	June 30, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04372797` - Standardized Instruments to Provide Diagnostic and Prognostic Information in Mild Traumatic Brain Injury (mTBI)	N/A
Completed	`NCT01903525` - DHA For The Treatment of Pediatric Concussion Related to Sports Injury	Phase 1
Completed	`NCT01847040` - Deployment Related Mild Traumatic Brain Injury (mTBI)
Completed	`NCT03678077` - Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury
Recruiting	`NCT05682677` - Combined Neuromodulation and Cognitive Training for Post-mTBI Depression	N/A
Terminated	`NCT03345550` - OPTIMA-TBI Pilot Study	Phase 2
Completed	`NCT05095012` - RECOVER Clinical Pathway for Pediatric Concussion	N/A
Recruiting	`NCT05886400` - The Effects of Environmental Distractions on SCAT6 Outcomes	N/A
Recruiting	`NCT05262361` - Persistent Post-Concussion Symptoms With Convergence Insufficiency	N/A
Active, not recruiting	`NCT03892291` - Objective Dual-task Turning Measures for Return-to-duty Assessments
Completed	`NCT03688984` - Treatment of Insomnia for Adolescents With Mild Traumatic Brain Injury	N/A
Completed	`NCT02057081` - Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI	N/A
Recruiting	`NCT06233851` - t-BIOMAP : Prospective Paediatric Cohort Study of Blood Biomarkers in mTBI
Completed	`NCT02844946` - One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology	N/A
Completed	`NCT04641767` - BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)
Recruiting	`NCT06112093` - Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches	N/A
Recruiting	`NCT03819608` - Neuromodulation and Neurorehabilitation for mTBI Plus PTSD	N/A
Withdrawn	`NCT00580918` - Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients
Completed	`NCT03319966` - Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
Recruiting	`NCT03846830` - Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Acute and Mild TBI Injury in Military and Civilian Population Using Advanced MR Imaging

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms