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

Completed

Conditions studied: Traumatic Brain Injury, Vision Difficulty

In brief

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.

Key facts

Study ID

NCT02771106

Run by

Hennepin Healthcare Research Institute

People needed

42

Starts

2016-06-01

Expected to finish

2020-08-21

Last updated by the study team

2020-10-19

Who can join

Age: 16 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Hennepin County Medical Cetner — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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