NCT02251002

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

2.6 years

First QC Date

September 22, 2014

Last Update Submit

March 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • frontoparietal priority maps

    baseline

  • white matter integrity

    baseline

Study Arms (2)

Control

no history of TBI or neurologic disorder

mTBI

documented past mild to moderate TBI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries, TraumaticOcular Motility Disorders

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCranial Nerve DiseasesEye Diseases

Study Officials

  • Cheryl A Olman, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2014

First Posted

September 26, 2014

Study Start

July 1, 2015

Primary Completion

February 1, 2018

Study Completion

October 1, 2018

Last Updated

March 21, 2019

Record last verified: 2019-03