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Frontoparietal Priority Maps as Biomarkers for MTBI

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ClinicalTrials.gov Identifier: NCT02251002
Recruitment Status : Completed
First Posted : September 26, 2014
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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).

Condition or disease
TBI (Traumatic Brain Injury) Ocular Motility Disorders

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.
Study Design
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Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Frontoparietal Priority Maps as Biomarkers for MTBI
Actual Study Start Date : July 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : October 2018
Groups and Cohorts
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Group/Cohort
Control
no history of TBI or neurologic disorder
mTBI
documented past mild to moderate TBI


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251002


Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Cheryl A Olman, PhD University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02251002    
Other Study ID Numbers: 1408M53005
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Ocular Motility Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cranial Nerve Diseases
Eye Diseases