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

NCT02771106 | Completed

• 1 other identifier: HSR #13-3702
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Vision Difficulty

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

control

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

Interventions

neuro vision rehabilitation OTHER

Neuro vision rehabilitation used to treat vision dysfunction following TBI

vision dysfunction

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have suffered a mild traumatic brain injury who fit the below inclusion/exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• University of Minnesota: collaborator

Study Sites (1)

Hennepin County Medical Cetner

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sarah B Rockswold, MD

  Minneapols Medical Research Foundation

  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: May 2, 2016
• First Posted: May 12, 2016
• Study Start: June 1, 2016
• Primary Completion: August 21, 2020
• Study Completion: August 21, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

US (1)