An observational study in Mild Traumatic Brain Injury, Brain Concussion and Convergence Insufficiency, sponsored by Hennepin Healthcare Research Institute. Completed at 1 site in United States. Open to participants aged 13 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by Hennepin Healthcare Research Institute · Observational
Among 418 studies in Brain Concussion with a site in United States — 100 open to participants now, 121 under way, 5 of them phase 3. Brain Concussion · United States.
Among the 418 studies in Brain Concussion with a site in United States, this one is the 61st largest by enrollment of the 96 observational ones that give a count, is one of 25 that started in 2017, is one of 96 observational ones, and was the 168th registered.
639 studies on the registry are indexed under Brain Concussion; 165 are open to participants now.
Browse Brain Concussion studies →100 of the 418 studies in Brain Concussion with a site in United States are open now. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
Ages 18–55
University of Michigan · Sites in United States
Ages 18+
Perception Dynamics Institute · Sites in United States
Ages 18–60
University of Colorado, Denver · Sites in United States
Ages 18+ · Men only
Akiva Cohen · Sites in United States
Ages 11–23 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 112 Brain Concussion studies recruiting now, 33 (29%) set no upper age limit and 72 (64%) stop at 75 or younger; 24 take children under 18; 38 take healthy volunteers.
This study: 13 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
418 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 28 · Phase 3 9 · Phase 4 5
First in 1998; this study’s year is marked. 25 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 92 is below the median of 149 across 167 observational studies indexed under Brain Concussion.
Median enrollment 60 across the 321 interventional studies, 147 across the 96 observational. Of the 259 that completed or were terminated, 68 (26%) have results posted.
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59 of 418 have an industry lead sponsor. The 10 most frequent:
Hennepin Healthcare Research Institute is the lead sponsor of 67 studies on the registry; 4 are open to participants now.
Hennepin Healthcare Research Institute has 1 study filed under Brain Concussion — fewer than ten, so there is no comparison to draw.
49 of the studies in Brain Concussion with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04867317Phase 3VA Office of Research and DevelopmentGrowth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD) | 2027-02-28 |
| NCT05320822University of North Carolina, Chapel HillA Pragmatic Rehabilitation Intervention: The Active Rehab Study | 2026-11-28 |
| NCT06109909VA Office of Research and DevelopmentPilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury | 2026-11-30 |
| NCT02670161Endeavor HealthQuality Improvement and Practice Based Research in Neurology Using the EMR | 2026-12 |
| NCT04708613David Okonkwo, MD, PhDUniversity of Pittsburgh Brain Health Initiative | 2026-12 |
Add all 49 to your calendar (.ics) → With an account.
Among the 418 studies in Brain Concussion with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this single center, longitudinal, pilot study is to provide evidence for the use of an eye tracking system as an objective tool to identify mild traumatic brain injury (mTBI) related oculomotor dysfunction (OMD) and predict the effectiveness of neurovision rehabilitation (NVR) of OMD. Eye tracking visual stimulus measurements will be compared to objective developmental optometrist (OD) diagnosis and assessments. It will be determined whether an eye tracking system can predict the presence or absence of mTBI related OMD and whether mTBI patients who have OMD based on the eye tracking system will respond positively to NVR.
The primary objectives are: 1) To demonstrate that measurements from visual stimulus and eye tracking system will predict the presence or absence of traumatic brain injury related vision disorder, i.e. oculomotor dysfunction (OMD) as diagnosed by a developmental optometrist (OD). 2) To use the eye tracking visual measurements to predict the effectiveness of neurovision rehabilitation (NVR) on post-traumatic OMD by comparing the data obtained to the objective visual measurements found on the OD examination.
Mild traumatic brain injury (mTBI) that alters brain function is a major public health concern of significant personal and societal burden. Mild traumatic brain injury patients may experience any or all of at least 20 symptoms, with some persisting for weeks to months and increasing the risk of comorbidities. Current mTBI diagnosis and treatment are subjective and imprecise rather than objective and patient specific. Despite the varied heterogeneous manifestations of mTBI based on location and severity of injury as well as predisposing factors, treatment is generic and lacking in active therapies: rest with the avoidance of devices/screens to avoid exacerbating symptoms. This "one size fits all" approach is suboptimal, often resulting in ineffective management with prolonged inadequate recovery. Recent evidence suggests effective therapies to be specific to the mTBI patient and their symptoms with promising interventions targeting vestibular deficits as well as post-TBI OMD NVR. Neurovision rehabilitation is analogous to physical therapy for the eyes and improves the connection between the brain and the eyes with prior research finding NVR to be very effective for patients with post-concussion visual dysfunctions. Patients with potential mTBI primarily present to the emergency department, primary care, or specialty clinic, where there lacks proper equipment, training, and time for a comprehensive vision examination. Additionally, identification and diagnosis of OMD is only conducted currently by a vision specialist or highly skilled TBI specialists. This leaves a majority of OMD patients with inappropriate diagnosis and inadequate work or school accommodations as well as without treatment with NVR, lenses, and prisms. Thus an objective, easily accessible tool to identify mTBI related OMD would greatly advance clinical care.
This trial is a single center, longitudinal, pilot study. One hundred mTBI patients with OMD, confirmed with objective testing by a OD, who fit inclusion/exclusion criteria will be initially identified by providers at the Hennepin County Medical Center (HCMC) TBI Clinic. No subject will be excluded on the basis of sex/gender, race or ethnicity. If interested, subjects will be consented then undergo an initial eye tracking. Within two weeks of the initial eye tracking, subjects will begin recommended NVR with occupational therapists (OT) at HCMC. Each NVR session will assess each subject's progress and following each NVR session, subjects will receive an eye tracking test. Additionally, within two months of the initial OMD diagnosis patients will follow up with the OD every two months until their OMD is resolved or until one year following their diagnosis. Subjects will also undergo an eye tracking test after each OD follow up appointment. Eye tracking visual stimulus measurements will be compared to OD diagnostic measurements and assessments.
The goals of this research study are to improve objective, timely identification of mTBI related visual dysfunctions and assessment of the effectiveness of NVR. A positive outcome will greatly impact diagnosis and care of mTBI patients with vision dysfunction, as objective assessments will be more widely and readily available and NVR will be more utilized by the medical community. Overall post-mTBI functional outcomes will improve, significantly lessening this major public health concern affecting patients, families, communities, and society.
Mild traumatic brain injury patients who meet the inclusion/exclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group consists of subjects with mTBI who have been diagnosed with OMD by objective OD measurements. These subjects will undergo neurovision rehabilitation used to treat oculomotor dysfunction following traumatic brain injury per usual clinical standard of care at the HCMC TBI Clinic.
Eye Tracker as an Objective Tool for "Yes/No" Assessment of Oculomotor Dysfunction Presence
Eye tracker metrics of oculomotor dysfunction as compared to objective developmental optometry diagnostic measurements.
Time frame: 12 months
Eye Tracking Visual Measurements as Objective Predictor of Neurovision Rehabilitation Effectiveness
Eye tracker metrics of oculomotor dysfunction status throughout neurovision rehabilitation as compared to objective developmental optometry follow up measurements and eye therapy exercise findings.
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Aug 2020, 34 months.
Of 72 non-industry observational studies under Brain Concussion, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 188. This study's 34 months is close to that.
Counting every sponsor, half of 94 studies reached it within 35 months; a quarter within 16 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Hennepin Healthcare Research Institute