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Traumatic Brain InjuryNCT02771106

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

An observational study of Traumatic Brain Injury and Vision Difficulty, run by Hennepin Healthcare Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 55 years
Conditions the study is for
Traumatic Brain Injury, Vision Difficulty
What is being tested?
neuro vision rehabilitation
How many people
42 participants
Where
1 siteUnited States
Study dates
1 Jun 2016to 21 Aug 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Hennepin County Medical Cetner

    Minneapolis, Minnesota, 55415

Other trials in United States

About this study

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.

Read the detailed description

The primary objectives are: 1) To localize changes following mild traumatic brain injury (mTBI) in subjects with vision dysfunction using functional magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI). 2) To demonstrate the effectiveness of neuro vision rehabilitation (NVR) on vision dysfunction initiated within nine months following mTBI by normalizing objective visual measurements as well as changes on fMRI and DTI.

Mild (TBI) comprises 80% of the 3.65 million brain injuries in the United States and costs an estimated 17 billion dollars annually. Mild TBI is a challenging diagnosis and can be as disabling as a severe TBI when chronic symptoms develop. In the past several years, researchers have found that a somewhat silent majority of mTBI patients who develop lasting symptoms have concurrent vision dysfunction. This cohort of patients with post-traumatic visual difficulty, regardless of mechanism of injury, seem to demonstrate more significant and lasting disability and poorer overall outcome than other TBI cohorts, yet these correlations have not been adequately studied. The studies that have been performed have found that visual dysfunctions may not spontaneously improve and become chronic in absence of direct diagnosis and treatment. Time after injury has been shown in studies to have no influence on incidence or frequency of visual difficulties but once identified, these pervasive visual dysfunctions significantly improve in response to interventions such as prescription glasses and NVR.

For the past 16 months, the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota (U of M) and the TBI Center at the Hennepin County Medical Center (HCMC) have closely collaborated in a pilot study. The goal of this study was to identify the location in the brain of post traumatic visual changes in acute mTBI subjects (< 9 months from injury date, ages 18-55) using resting state and task fMRI and DTI. Mild TBI subjects who had vision dysfunction (vision group) were compared to mTBI subjects who did not have any vision difficulties (controls). Task fMRI imaging demonstrated significant decreased brain activity in the vision dysfunction subjects as compared to the controls in certain key vision areas. Diffusion tensor imaging showed significant changes in certain areas of the corpus callosum.

This trial is designed as a longitudinal clinical study. Fifteen mTBI patients with vision dysfunction (vision group) fitting the inclusion/exclusion criteria and 15 patients with mTBI but with no findings on the visual screen (control group) within 9 months of their injury will be included in the study. No subject will be excluded on the basis of sex/gender, race or ethnicity. These mTBI subjects will initially be identified by physicians in the HCMC TBI Clinic. If agreeable, consent will be obtained at both HCMC as well as prior to their baseline MRI scans at CMRR. The subjects will then undergo objective testing by a specialized eye doctor at HCMC to confirm if they do or do not have vision dysfunction related to the mTBI. At CMRR, within 2 weeks of the visual testing, the whole brain will be imaged using resting state and task fMRI and DTI using a 3T MRI machine. The subjects will then receive neurovision rehabilitation for approximately 3 months at HCMC if they are in the vision group. This treatment is standard care for this population. Both groups will then undergo repeat objective vision testing by the specialized eye doctor 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.

Mild TBI is a significant cause of disability especially when symptoms become chronic. In HCMC's clinical experience, this chronicity is often linked to vision difficulties. Vision dysfunction will continue until properly identified and treated, especially with neuro vision rehabilitation. The goals of this research study are to better understand cerebral structural and metabolic changes associated with as well as the effectiveness of neuro vision rehabilitation on post traumatic vision dysfunction by utilizing resting state and task fMRI and DTI. A positive outcome will have a significant impact on the diagnosis and care of the considerable numbers of mTBI patients suffering from vision dysfunction, especially because neurovision rehabilitation will be more utilized by the medical community. In turn, the overall functional outcomes after mTBI will improve, greatly relieving the suffering and disability for these patients.

Being tested
neuro vision rehabilitation
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • neuro vision rehabilitationOther

    Neuro vision rehabilitation used to treat vision dysfunction following TBI

Study groups in NCT02771106
Study groupRoleWhat they receive
vision dysfunctionThis 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.
Receives: Other: neuro vision rehabilitation
controlThis group are subjects with mild TBI who have no oculomotor (vision) dysfunction per objective measurements taken by the HCMC developmental optometrist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To localize changes following mild traumatic brain injury in subjects with vision dysfunction using magnetic resonance imaging (MRI).

    Measured: 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.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2016 (estimated)
  2. Study start1 Jun 2016
  3. Primary completion21 Aug 2020
  4. Study completion21 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02771106
Sponsor's protocol ID
HSR #13-3702
Status last verified
Oct 2020
First submitted
2 May 2016
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injury and Vision Difficulty, run by Hennepin Healthcare Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To localize changes following mild traumatic brain injury in subjects with vision dysfunction using magnetic resonance imaging (MRI). (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.

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