Frontoparietal Priority Maps as Biomarkers for MTBI

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

Frontoparietal Priority Maps as Biomarkers for MTBI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251002
• Other study ID #: 1408M53005
• Status: Completed
• Start date: July 2015
• Est. completion date: October 2018

Study information

• Verified date: March 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Ocular Motility Disorders
• TBI (Traumatic Brain Injury)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	frontoparietal priority maps	Functional MRI data will be collected at 7 Tesla while subjects perform spatial attention and eye movement tasks.	baseline
Secondary	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