Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Frontoparietal Priority Maps as Biomarkers for MTBI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date September 22, 2014
First Posted Date September 26, 2014
Last Update Posted Date March 21, 2019
Actual Study Start Date July 2015
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 24, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 24, 2014)
  • frontoparietal priority maps [ Time Frame: baseline ]
    Functional MRI data will be collected at 7 Tesla while subjects perform spatial attention and eye movement tasks.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Frontoparietal Priority Maps as Biomarkers for MTBI
Official Title Frontoparietal Priority Maps as Biomarkers for MTBI
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).
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • TBI (Traumatic Brain Injury)
  • Ocular Motility Disorders
Intervention Not Provided
Study Groups/Cohorts
  • Control
    no history of TBI or neurologic disorder
  • mTBI
    documented past mild to moderate TBI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 24, 2014)
88
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2018
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02251002
Other Study ID Numbers 1408M53005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Minnesota
Study Sponsor University of Minnesota
Collaborators Not Provided
Investigators
Principal Investigator: Cheryl A Olman, PhD University of Minnesota
PRS Account University of Minnesota
Verification Date March 2019