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Neuroimaging and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT02771106
Recruitment Status : Active, not recruiting
First Posted : May 12, 2016
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation

Brief Summary:
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.

Condition or disease Intervention/treatment
Traumatic Brain Injury Vision Difficulty Other: neuro vision rehabilitation

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Neuroimaging and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
Study Start Date : June 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
vision dysfunction
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.
Other: neuro vision rehabilitation
Neuro vision rehabilitation used to treat vision dysfunction following TBI

control
This group are subjects with mild TBI who have no oculomotor (vision) dysfunction per objective measurements taken by the HCMC developmental optometrist



Primary Outcome Measures :
  1. To localize changes following mild traumatic brain injury in subjects with vision dysfunction using magnetic resonance imaging (MRI). [ Time Frame: 18 months ]
  2. 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. [ Time Frame: 18 months ]


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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have suffered a mild traumatic brain injury who fit the below inclusion/exclusion criteria.
Criteria

Inclusion Criteria:

  • Mild TBI (GCS score > 13), Post Traumatic Amnesia < 24 hours, no brain CT findings
  • Diagnosed with vision dysfunction by developmental optometrist
  • Age equal to or > 16 years- 55 years.
  • Injury between 1 - 9 months
  • Informed consent obtained

Exclusion Criteria:

  • Any type of bio-implant activated by mechanical, electronic, or magnetic means
  • Any type of ferromagnetic bio-implant that could potentially be displaced
  • Pregnant females
  • Significant anxiety and/or claustrophobia
  • Subjects who cannot adhere to the experimental protocol
  • Brain tumor or stroke or severe traumatic brain injury or history of severe mental retardation
  • Any chemotherapy, immunomodulatory agents, or radiation treatment affecting the brain
  • Two or more seizures, or been given a diagnosis of epilepsy
  • Known ocular problems including orbital fractures, monocular vision, strabismus, - Lasik surgery for monofixation, cataracts with visual acuity > 20/40
  • History of intractable migraines
  • History of major psychiatric disorder
  • Taking medications which interfere with visual process
  • Taking illicit drugs such as marijuana, cocaine, heroin, etc
  • Age < 16 and > 55 years
  • GCS score < 13
  • Current TBI or still symptomatic from prior mTBI > 9 months
  • Any vision rehabilitation
  • Near point convergence > 70 cm or sustained diplopia
  • Cranial nerve II, III, IV, or VI palsy
  • Any findings on clinical brain CT or MRI
  • Any subject with a professional or academic link to the PI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771106


Locations
United States, Minnesota
Hennepin County Medical Cetner
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Minneapolis Medical Research Foundation
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Sarah B Rockswold, MD Minneapols Medical Research Foundation

Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02771106     History of Changes
Other Study ID Numbers: HSR #13-3702
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating