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OpenTrials
Completed

NCT Number: NCT02251002

Frontoparietal Priority Maps as Biomarkers for MTBI

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Primary outcomes

  1. oculomotor performance

    Time frame: study enrollment / baseline

    Oculomotor performance will be measured with behavioral questionnaires, eye-charts, and computerized eye-tracking while subjects perform saccades and smooth pursuit motions.

Secondary outcomes

  1. frontoparietal priority maps

    Time frame: baseline

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

  2. white matter integrity

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 26, 2014
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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