NCT02771106|Completed
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Sponsor study identifier
observational
42
1 country
1
Study Start
June 1, 2016
Actual (reported)Primary Completion
August 21, 2020
Actual (reported)Study Completion
August 21, 2020
Actual (reported)Mild TBI subjects will initially be identified by providers in the Hennepin County Medical Center (HCMC) TBI Clinic. The subjects will then undergo objective testing by the developmental optometrist to confirm if they do or do not have vision dysfunction related to the mTBI. At the Center of Magnetic Resonance Research (CMRR) located at the University of Minnesota (U of M), the whole brain will be imaged using resting state and task functional MRI and diffuse tensor imaging (DTI) using a high field 3 Tesla (T) MRI. The subjects will then receive neurovision rehabilitation if they are in the vision dysfunction group. This treatment is standard care. Both groups will then undergo repeat objective vision testing by the developmental optometrist at 3 and 6 months to confirm that vision dysfunction has resolved. Resting state and task fMRI and DTI will be done at the same time to compare functional and structural connectivity changes between the 2 groups.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 21, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2, 2016
Actual (reported)May 12, 2016
Actual (reported)June 1, 2016
Actual (reported)August 21, 2020
Actual (reported)August 21, 2020
Actual (reported)To localize changes following mild traumatic brain injury in subjects with vision dysfunction using magnetic resonance imaging (MRI).
18 months
2) The effectiveness of neuro vision rehabilitation on vision dysfunction initiated within nine months following mTBI will be shown using magnetic resonance imaging by comparing aggregate data of 15 vision dysfunction subjects to 15 control subjects.
18 months
This group are subjects with mild TBI who have been diagnosed with profound oculomotor (vision) dysfunction per objective measurements taken by the HCMC developmental optometrist. These subjects will undergo neuro vision rehabilitation.
This group are subjects with mild TBI who have no oculomotor (vision) dysfunction per objective measurements taken by the HCMC developmental optometrist
Neuro vision rehabilitation used to treat vision dysfunction following TBI
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subjects who have suffered a mild traumatic brain injury who fit the below inclusion/exclusion criteria.
Hennepin County Medical Cetner
Minneapolis, Minnesota, 55415, United States
Sarah B Rockswold, MD
Minneapols Medical Research Foundation
42 participants (actual enrollment reported by the registry).
First Submitted
May 2, 2016
First Posted
May 12, 2016
Study Start
June 1, 2016
Actual (reported)Mild TBI Assessment & Rehabilitation
Contact the study team to confirm eligibility.
Primary Completion
August 21, 2020
Actual (reported)Study Completion
August 21, 2020
Actual (reported)Last Updated
October 19, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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