Frontoparietal Priority Maps as Biomarkers for MTBI

NCT ID: NCT02251002

Last Updated: 2019-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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TBI (Traumatic Brain Injury) Ocular Motility Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

no history of TBI or neurologic disorder

No interventions assigned to this group

mTBI

documented past mild to moderate TBI

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheryl A Olman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Other Identifiers

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1408M53005

Identifier Type: -

Identifier Source: org_study_id

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