Frontoparietal Priority Maps as Biomarkers for MTBI
1 other identifier
observational
88
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether there is a quantitative relationship between brain processes seen by a MRI and visual deficits caused by mild to moderate traumatic brain injuries (mTBI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2015
Typical duration for all trials
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 22, 2014
CompletedFirst Posted
Study publicly available on registry
September 26, 2014
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedMarch 21, 2019
March 1, 2019
2.6 years
September 22, 2014
March 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
oculomotor performance
Oculomotor performance will be measured with behavioral questionnaires, eye-charts, and computerized eye-tracking while subjects perform saccades and smooth pursuit motions.
study enrollment / baseline
Secondary Outcomes (2)
frontoparietal priority maps
baseline
white matter integrity
baseline
Study Arms (2)
Control
no history of TBI or neurologic disorder
mTBI
documented past mild to moderate TBI
Eligibility Criteria
Participants with mTBI who have previously participated in MRI studies; preference will be given to individuals with visual complaints such as blurred or double vision or headaches while reading. Participants with no history of TBI and no visual complaints will also be recruited into a control group.
You may qualify if:
- Normal or corrected to normal visual acuity
- No previously documented mTBI (target: 16 out of 88 participants invited for Visit 1)
- Previously documented mTBI (target: 72 out of 88 participants invited for Visit 1)
- Vision impairment (target: 48 out of 88 participants invited for Visit 1; expected to be comorbid with mTBI, but non-TBI participants with oculomotor impairments will not be excluded)
You may not qualify if:
- Current use of neuroactive drugs or medications
- Presence of neurological disorders (other than mTBI and mild PTSD)
- Contraindications for MRI (metal in the body, claustrophobia, diabetes or other diseases or drugs that affect thermoregulation)
- Inability to comply with behavioral task instructions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheryl A Olman, PhD
University of Minnesota
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2014
First Posted
September 26, 2014
Study Start
July 1, 2015
Primary Completion
February 1, 2018
Study Completion
October 1, 2018
Last Updated
March 21, 2019
Record last verified: 2019-03