Traumatic Brain InjuryBASHNCT02706574
Brain Injury Assessment Study at Hennepin County Medical Center
An observational study of Traumatic Brain Injury, run by CentraCare.
Trial summary
The goals of this study are to develop an objective, multi-modal classification scheme and outcome measures for traumatic brain injury based on several measures: (1) blood-based biomarkers (indicates which cell types are damaged), (2) eye tracking (detects mass effect/elevated intracranial pressure and pathway… Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 774 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jul 2022
- 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will include all trauma patients that present to the HCMC Emergency Department, trauma bay or as a direct transfer to neurosurgery.
Who may be able to join
- All trauma patients that present to Hennepin County Medical Center.
Who cannot join
- Age > 4 years old;
- Major psychiatric or neurologic disorder: Active Psychotic Break, Trauma due to Suicide Attempt, Epilepsy, Multiple Sclerosis, Dementia, Guillain Barre Syndrome/Chronic Inflammatory Demyelinating Polyneuropathy, Significant Neurodegenerative Disorders, Muscular Dystrophy, and/or Malignant Intracranial Mass with Significant Mass Effect.
- Developmentally Abnormal, or
- Prisoners.
About this study
The goals of this study are to develop an objective, multi-modal classification scheme and outcome measures for traumatic brain injury based on several measures: (1) blood-based biomarkers (indicates which cell types are damaged), (2) eye tracking (detects mass effect/elevated intracranial pressure and pathway disruption), (3) radiographic measures of CT and MRI (detect structural abnormalities), and (4) standardized outcome assessments.
Read the detailed description
Background:
Current algorithms for assessment of the severity of brain injury include Glasgow Coma Scale score and other measures. These measures are adequate for relating acute severity but are insufficiently sensitive for subtle pathology which can result in persistent deficit. The Glasgow Coma Scale (GCS) and other measures also do not enable differentiation among types of injury. Thus patients grouped into a single GCS level entering a clinical trial may have vastly heterogeneous severity and type of injury. Because outcomes also vary accordingly, inappropriate classification undermines the integrity of a clinical trial. Improved classification of injury will enable more precise delineation of disease severity and type for patients with a traumatic brain injury (TBI) in clinical trials.
Additionally, current brain injury trials rely on outcome measures such as Glasgow Outcome Scale Extended, which capture global phenomena but fail to assess for subtle differences in outcome. Thus, many recent trials for brain injury therapeutics have failed. Sensitive outcome measures are needed to determine how well patients have recovered from brain injury in order to test therapeutics and prophylactics.
Overview of Methods:
All trauma patients that span the full spectrum ranging from non-brain injured, to CT-negative, to structurally brain injured, requiring surgery will be included in this study. A total of 1000 patients and 200 controls will be recruited over approximately 2 years.
The study has been approved by the Institutional Review Board (IRB), enabling a waiver of consent for all trauma patients until it becomes appropriate to obtain consent. The trauma patients will be screened upon admission, and potentially during the period of waived consent, for participation in the study (target N for screening = 16,000 per year). The screening process will include:
- A standardized history and physical examination done as a part of the standard of care.
- A standardized assessment to be done by research personnel.
- Eye tracking.
- Analysis of serum biomarkers at three time points within the first 24 hours.
- MRI scans for a subset of patients within one week of their injury.
- CT scans as clinically indicated.
- Pathologic specimen as clinically indicated.
- Cerebrospinal fluid (CSF) analysis in patients that receive a ventriculostomy catheter.
- Brain tissue oxygenation analysis in patients receiving Licox.
The screening process that takes place, potentially during the period of waived consent, will allow for patients to be stratified into the following groups with the associated targeted sample sizes over two years:
- Isolated TBI (N=400)
- Combined TBI and Body Trauma (N=400)
- Isolated Body Trauma (N=200)
- Healthy, Uninjured Controls (N=200)
Upon discharge, patients will be recruited to enroll in a long-term follow-up assessment. They will be seen in the hospital at the following time points post-injury: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year. At these follow-up visits, participants will be asked to undergo various assessments depending on the follow-up visit, including:
- Eye Tracking.
- Blood draw for blood-based biomarker analysis.
- MRI scan if they had one within one week post-injury.
- CT scan if they had one at admission.
- Cognitive, Neurologic, and Quality of Life Assessments
Data Analysis:
Patient outcomes, measured with sensitive outcome measures, will be linked to acute research findings in order to create a classification scheme for brain injury that is based on objective measures and can accurately predict prognosis.
- Conditions
- Traumatic Brain Injury
- Keywords
- Eye Tracking, Blood-based Biomarkers, CSF-based Biomarkers, Magnetic Resonance Imaging, Computed Tomography Scan, Outcome Measures
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Isolated Traumatic Brain Injury | This group will present to our Level 1 Trauma Center with a Traumatic Brain Injury and no other associated injuries. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners. | |
| Isolated Body Trauma | This group will present to our Level 1 Trauma Center as a trauma patient with no injury to their head. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners. | |
| Combined Traumatic Brain Injury and Body Trauma | This group will present to our Level 1 Trauma Center as a trauma patient that had injuries to both their head and body. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners. | |
| Healthy, Uninjured Controls | This group will consist of subjects that have not been exposed to any major trauma in the previous 12 months. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Metrics of Eye Movements during Recovery as Measured by Eye Tracking
Patients will watch a video for 220 seconds as it moves clockwise around the perimeter of a monitor at about 10 seconds per side, resulting in 5 complete rotations of 40 seconds each. As the patient watches the video, their eye movements will be recorded by a camera.
Measured: Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.
Change in Proteomic Concentrations of Blood-Based Biomarkers during Recovery as Measured by Blood Draws
Blood will be drawn for proteomic analysis at each follow-up time point. Blood will also be drawn acutely for genomic analysis.
Measured: Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.
Change in Observable Neural Abnormalities as measured by Magnetic Resonance Imaging
A group of patients will be selected based on presenting symptoms to undergo a MRI within a week of their injury and again 1 year after their injury. The sequences for these scans will include T2 Flair, susceptibility weighted imaging, diffusion weighted imaging, and diffusion tensor imaging.
Measured: Post-Injury Time Points of Data Collection: within 1 week and at 1 year.
Computed Tomography Scan
A group of patients that had an acute CT scan at admission will be selected based on presenting symptoms to undergo a CT scan at 1 year post-injury.
Measured: Post-Injury Time Point of Data Collection: 1 year.
Secondary outcomes (7)
Change in Neurological Examination during Recovery as Measured by the Neurological Outcome Scale after Traumatic Brain Injury
The Neurological Outcome Scale for Traumatic Brain Injury is a standardized neurological examination validated specifically for patients with Traumatic Brain Injury.
Measured: Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.
Change in Cognitive Function and Symptom Severity during Recovery as Measured with the Sports Concussion Assessment Tool 3 (SCAT3)
The Standardized Assessment of Concussion and Symptom Severity Scale subscores of the SCAT3 will be done at every follow-up time point to assess cognitive functioning and symptom severity, respectively, as the patients' recovery progresses.
Measured: Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.
Change in Quality of Life during Recovery as Measured with the Mayo-Portland Adaptability Inventory-4 (MPAI-4)
The MPAI-4 is a standardized and comprehensive quality of life assessment that will be used to assess self-reported quality of life as the patients' recovery progresses.
Measured: Post-Injury Time Points of Data Collection: 3 months, and 1 year.
Change in Global Outcome during Recovery as Measured with the Glasgow Outcome Scale-Extended (GOS-E)
The GOS-E is commonly used in traumatic brain injury research to assess global changes in disability following traumatic brain injury as the patients' recovery progresses.
Measured: Post-Injury Time Points of Data Collection: 3 months, 6 months, and 1 year.
Change in Memory Performance during Recovery as Measured with the Galveston Orientation and Amnesia Test (GOAT)
The GOAT is commonly used in traumatic brain injury research to assess global changes in memory performance following traumatic brain injury as the patients' recovery progresses.
Measured: Post-Injury Time Points of Data Collection: 3 months and 1 year.
The Number of Prior Brain Injuries the Patient has Suffered as Measured with the Boston Assessment of Traumatic Brain Injury-Lifetime
This comprehensive and validated tool will allow for an accurate assessment of how many prior brain injuries a patient has had.
Measured: Post-Injury Time Point of Data Collection: 2 weeks.
Change in Cognitive Functioning during Recovery as Measured by the Brief Test of Adult Cognition by Telephone
This test of cognitive function will be used for those patients that are not able to come to the hospital for follow-up assessments.
Measured: Post-Injury Time Points of Data Collection: 3 months and 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 774 participants (actual)
Sponsor and investigators
- Lead sponsor
- CentraCare
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Diagnostics Division
- Responsible party
- Sponsor
- Investigators
- Uzma Samadani, MD, PhD, Principal investigator, Physician, Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706574
- Sponsor's protocol ID
- HSR 15-4079
- Acronym
- BASH
- Status last verified
- Feb 2021
- First submitted
- 29 Feb 2016
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Samadani U. A new tool for monitoring brain function: eye tracking goes beyond assessing attention to measuring central nervous system physiology. Neural Regen Res. 2015 Aug;10(8):1231-3. doi: 10.4103/1673-5374.162752. No abstract available.
PubMed 26487847Samadani U, Ritlop R, Reyes M, Nehrbass E, Li M, Lamm E, Schneider J, Shimunov D, Sava M, Kolecki R, Burris P, Altomare L, Mehmood T, Smith T, Huang JH, McStay C, Todd SR, Qian M, Kondziolka D, Wall S, Huang P. Eye tracking detects disconjugate eye movements associated with structural traumatic brain injury and concussion. J Neurotrauma. 2015 Apr 15;32(8):548-56. doi: 10.1089/neu.2014.3687. Epub 2015 Feb 6.
PubMed 25582436Samadani U, Farooq S, Ritlop R, Warren F, Reyes M, Lamm E, Alex A, Nehrbass E, Kolecki R, Jureller M, Schneider J, Chen A, Shi C, Mendhiratta N, Huang JH, Qian M, Kwak R, Mikheev A, Rusinek H, George A, Fergus R, Kondziolka D, Huang PP, Smith RT. Detection of third and sixth cranial nerve palsies with a novel method for eye tracking while watching a short film clip. J Neurosurg. 2015 Mar;122(3):707-20. doi: 10.3171/2014.10.JNS14762. Epub 2014 Dec 12.
PubMed 25495739
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Injury Assessment Study at Hennepin County Medical Center
- ClinicalTrials.gov ID
- NCT02706574
- Acronym / sponsor ID
- BASH / HSR 15-4079
- Conditions
- Traumatic Brain Injury
- Keywords
- Eye Tracking, Blood-based Biomarkers, CSF-based Biomarkers, Magnetic Resonance Imaging, Computed Tomography Scan, Outcome Measures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 774 participants (actual)
- Lead sponsor
- CentraCareUniversity, hospital or other
- Collaborators
- Abbott Diagnostics Division
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 11 Mar 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.
The goals of this study are to develop an objective, multi-modal classification scheme and outcome measures for traumatic brain injury based on several measures: (1) blood-based biomarkers (indicates which cell types are damaged), (2) eye tracking (detects mass effect/elevated intracranial pressure and pathway disruption), (3) radiographic measures of CT and MRI (detect structural abnormalities), and (4) standardized outcome assessments.
Detailed description
Background:
Current algorithms for assessment of the severity of brain injury include Glasgow Coma Scale score and other measures. These measures are adequate for relating acute severity but are insufficiently sensitive for subtle pathology which can result in persistent deficit. The Glasgow Coma Scale (GCS) and other measures also do not enable differentiation among types of injury. Thus patients grouped into a single GCS level entering a clinical trial may have vastly heterogeneous severity and type of injury. Because outcomes also vary accordingly, inappropriate classification undermines the integrity of a clinical trial. Improved classification of injury will enable more precise delineation of disease severity and type for patients with a traumatic brain injury (TBI) in clinical trials.
Additionally, current brain injury trials rely on outcome measures such as Glasgow Outcome Scale Extended, which capture global phenomena but fail to assess for subtle differences in outcome. Thus, many recent trials for brain injury therapeutics have failed. Sensitive outcome measures are needed to determine how well patients have recovered from brain injury in order to test therapeutics and prophylactics.
Overview of Methods:
All trauma patients that span the full spectrum ranging from non-brain injured, to CT-negative, to structurally brain injured, requiring surgery will be included in this study. A total of 1000 patients and 200 controls will be recruited over approximately 2 years.
The study has been approved by the Institutional Review Board (IRB), enabling a waiver of consent for all trauma patients until it becomes appropriate to obtain consent. The trauma patients will be screened upon admission, and potentially during the period of waived consent, for participation in the study (target N for screening = 16,000 per year). The screening process will include:
- A standardized history and physical examination done as a part of the standard of care.
- A standardized assessment to be done by research personnel.
- Eye tracking.
- Analysis of serum biomarkers at three time points within the first 24 hours.
- MRI scans for a subset of patients within one week of their injury.
- CT scans as clinically indicated.
- Pathologic specimen as clinically indicated.
- Cerebrospinal fluid (CSF) analysis in patients that receive a ventriculostomy catheter.
- Brain tissue oxygenation analysis in patients receiving Licox.
The screening process that takes place, potentially during the period of waived consent, will allow for patients to be stratified into the following groups with the associated targeted sample sizes over two years:
- Isolated TBI (N=400)
- Combined TBI and Body Trauma (N=400)
- Isolated Body Trauma (N=200)
- Healthy, Uninjured Controls (N=200)
Upon discharge, patients will be recruited to enroll in a long-term follow-up assessment. They will be seen in the hospital at the following time points post-injury: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year. At these follow-up visits, participants will be asked to undergo various assessments depending on the follow-up visit, including:
- Eye Tracking.
- Blood draw for blood-based biomarker analysis.
- MRI scan if they had one within one week post-injury.
- CT scan if they had one at admission.
- Cognitive, Neurologic, and Quality of Life Assessments
Data Analysis:
Patient outcomes, measured with sensitive outcome measures, will be linked to acute research findings in order to create a classification scheme for brain injury that is based on objective measures and can accurately predict prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Isolated Traumatic Brain Injury | – | –This group will present to our Level 1 Trauma Center with a Traumatic Brain Injury and no other associated injuries. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners. |
| Isolated Body Trauma | – | –This group will present to our Level 1 Trauma Center as a trauma patient with no injury to their head. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners. |
| Combined Traumatic Brain Injury and Body Trauma | – | –This group will present to our Level 1 Trauma Center as a trauma patient that had injuries to both their head and body. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners. |
| Healthy, Uninjured Controls | – | –This group will consist of subjects that have not been exposed to any major trauma in the previous 12 months. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will include all trauma patients that present to the HCMC Emergency Department, trauma bay or as a direct transfer to neurosurgery.
Key inclusion criteria (1 listed)
- All trauma patients that present to Hennepin County Medical Center.
Key exclusion criteria (4 listed)
- Age > 4 years old;
- Major psychiatric or neurologic disorder: Active Psychotic Break, Trauma due to Suicide Attempt, Epilepsy, Multiple Sclerosis, Dementia, Guillain Barre Syndrome/Chronic Inflammatory Demyelinating Polyneuropathy, Significant Neurodegenerative Disorders, Muscular Dystrophy, and/or Malignant Intracranial Mass with Significant Mass Effect.
- Developmentally Abnormal, or
- Prisoners.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Metrics of Eye Movements during Recovery as Measured by Eye Tracking
Time frame: Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.
Patients will watch a video for 220 seconds as it moves clockwise around the perimeter of a monitor at about 10 seconds per side, resulting in 5 complete rotations of 40 seconds each. As the patient watches the video, their eye movements will be recorded by a camera.
Change in Proteomic Concentrations of Blood-Based Biomarkers during Recovery as Measured by Blood Draws
Time frame: Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.
Blood will be drawn for proteomic analysis at each follow-up time point. Blood will also be drawn acutely for genomic analysis.
Change in Observable Neural Abnormalities as measured by Magnetic Resonance Imaging
Time frame: Post-Injury Time Points of Data Collection: within 1 week and at 1 year.
A group of patients will be selected based on presenting symptoms to undergo a MRI within a week of their injury and again 1 year after their injury. The sequences for these scans will include T2 Flair, susceptibility weighted imaging, diffusion weighted imaging, and diffusion tensor imaging.
Computed Tomography Scan
Time frame: Post-Injury Time Point of Data Collection: 1 year.
A group of patients that had an acute CT scan at admission will be selected based on presenting symptoms to undergo a CT scan at 1 year post-injury.
7 secondary outcomes
Change in Neurological Examination during Recovery as Measured by the Neurological Outcome Scale after Traumatic Brain Injury
Time frame: Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.
Change in Cognitive Function and Symptom Severity during Recovery as Measured with the Sports Concussion Assessment Tool 3 (SCAT3)
Time frame: Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.
Change in Quality of Life during Recovery as Measured with the Mayo-Portland Adaptability Inventory-4 (MPAI-4)
Time frame: Post-Injury Time Points of Data Collection: 3 months, and 1 year.
Change in Global Outcome during Recovery as Measured with the Glasgow Outcome Scale-Extended (GOS-E)
Time frame: Post-Injury Time Points of Data Collection: 3 months, 6 months, and 1 year.
Change in Memory Performance during Recovery as Measured with the Galveston Orientation and Amnesia Test (GOAT)
Time frame: Post-Injury Time Points of Data Collection: 3 months and 1 year.
The Number of Prior Brain Injuries the Patient has Suffered as Measured with the Boston Assessment of Traumatic Brain Injury-Lifetime
Time frame: Post-Injury Time Point of Data Collection: 2 weeks.
Change in Cognitive Functioning during Recovery as Measured by the Brief Test of Adult Cognition by Telephone
Time frame: Post-Injury Time Points of Data Collection: 3 months and 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Background: PubMed 26487847Samadani U. A new tool for monitoring brain function: eye tracking goes beyond assessing attention to measuring central nervous system physiology. Neural Regen Res. 2015 Aug;10(8):1231-3. doi: 10.4103/1673-5374.162752. No abstract available.
- Background: PubMed 25582436Samadani U, Ritlop R, Reyes M, Nehrbass E, Li M, Lamm E, Schneider J, Shimunov D, Sava M, Kolecki R, Burris P, Altomare L, Mehmood T, Smith T, Huang JH, McStay C, Todd SR, Qian M, Kondziolka D, Wall S, Huang P. Eye tracking detects disconjugate eye movements associated with structural traumatic brain injury and concussion. J Neurotrauma. 2015 Apr 15;32(8):548-56. doi: 10.1089/neu.2014.3687. Epub 2015 Feb 6.
- Background: PubMed 25495739Samadani U, Farooq S, Ritlop R, Warren F, Reyes M, Lamm E, Alex A, Nehrbass E, Kolecki R, Jureller M, Schneider J, Chen A, Shi C, Mendhiratta N, Huang JH, Qian M, Kwak R, Mikheev A, Rusinek H, George A, Fergus R, Kondziolka D, Huang PP, Smith RT. Detection of third and sixth cranial nerve palsies with a novel method for eye tracking while watching a short film clip. J Neurosurg. 2015 Mar;122(3):707-20. doi: 10.3171/2014.10.JNS14762. Epub 2014 Dec 12.
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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.
Uzma Samadani, MD, PhD principal investigator
Physician, Neurosurgery
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by CentraCare.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Change in Metrics of Eye Movements during Recovery as Measured by Eye Tracking (time frame: Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02706574, which also lists 3 linked publications.
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 4 Feb 2021.