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.
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
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.
- Conditions
- Traumatic Brain Injury, Vision Difficulty
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To localize changes following mild traumatic brain injury in subjects with vision dysfunction using magnetic resonance imaging (MRI).
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start1 Jun 2016
- Primary completion21 Aug 2020
- Study completion21 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Sarah B Rockswold, MD, Principal investigator, Minneapols Medical Research Foundation
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02771106
- Acronym / sponsor ID
- HSR #13-3702
- Conditions
- Traumatic Brain Injury, Vision Difficulty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 21 Aug 2020 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vision dysfunction | – | Other: neuro vision rehabilitationThis 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. |
| control | – | –This group are subjects with mild TBI who have no oculomotor (vision) dysfunction per objective measurements taken by the HCMC developmental optometrist |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects who have suffered a mild traumatic brain injury who fit the below inclusion/exclusion criteria.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuro vision rehabilitationNeuro vision rehabilitation used to treat vision dysfunction following TBI | Other | vision dysfunction |
Primary outcome
To localize changes following mild traumatic brain injury in subjects with vision dysfunction using magnetic resonance imaging (MRI).
Time frame: 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.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah B Rockswold, MD principal investigator
Minneapols Medical Research Foundation
1 site in 1 country: see every site and its status.
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.