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CompletedNCT02251002Updated Mar 21, 2019

Frontoparietal Priority Maps as Biomarkers for MTBI

An observational study in TBI (Traumatic Brain Injury) and Ocular Motility Disorders, sponsored by University of Minnesota. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-21.

Sponsored by University of Minnesota · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
88
Ages
18 Years and older
Sex
All
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Study 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).

Read the detailed description

Participants with mTBI, as well as healthy control participants, will be invited to participate in up to two study visits. Both visits will occur at the University of Minnesota's Center for Magnetic Resonance Research (CMRR). The first study visit will entail (1) interviews to determine the presence of (and, if present, the severity of) oculomotor difficulties such as convergence insufficiency, and (2) behavioral measures (e.g., visually track a moving dot) to assess skill at allocating spatial attention. For participants who have not before participated in an MRI study at the CMRR, a 15-minute scan to acquire research-quality anatomical images of the brain will be acquired at the end of the first visit. A subset of the approximately 88 participants who participate in Visit 1 will be invited to participate in Visit 2. Visit 2 will be dominated by a 90-minute scanning session in the 7 Tesla scanner, during which participants will perform a 10-minute spatial attention task and a 10-minute eye movement task, and high-resolution diffusion tensor imaging data will be acquired while participants enjoy the movie of their choice in the scanner.

02

Conditions studied

  • TBI (Traumatic Brain Injury)
  • Ocular Motility Disorders
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 88 is below the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
88 participants (actual)
Patient registry
No

Groups and cohorts

  • Control

    no history of TBI or neurologic disorder

  • mTBI

    documented past mild to moderate TBI

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What researchers measure

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.

    Time frame: study enrollment / baseline

Secondary outcomes

  1. frontoparietal priority maps

    Functional MRI data will be collected at 7 Tesla while subjects perform spatial attention and eye movement tasks.

    Time frame: baseline

  2. white matter integrity

    Diffusion tensor imaging data will be acquired at 7 Tesla and analyzed in a priori regions of interest adjacent to frontal and parietal functional regions of interest.

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02251002
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Sep 26, 2014
Start date
Jul 2015
Primary completion
Feb 2018
Completion
Oct 2018
Last update
Mar 21, 2019

Study contacts

Cheryl A Olman, PhD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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