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).

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 88

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control; no history of TBI or neurologic disorder
mTBI; documented past mild to moderate TBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
frontoparietal priority maps	Functional MRI data will be collected at 7 Tesla while subjects perform spatial attention and eye movement tasks.	baseline
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.	baseline

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Cheryl A Olman, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: September 22, 2014
• First Submitted That Met QC Criteria: September 24, 2014
• First Posted (Estimate): September 26, 2014

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Brain Injuries; Brain Injuries, Traumatic; Ocular Motility Disorders
• Other Study ID Numbers: 1408M53005