ConcussionCAPITNCT02119533
Concussion and Post Traumatic Stress in Traumatic Brain Injury
An observational study of Concussion and Stress Disorders, Post-Traumatic, run by NYU Langone Health at 1 site in United States.
Trial summary
Mild brain injury or concussion affects about four million Americans each year. Some people recover completely while others, especially those with multiple concussions, develop chronic headaches, neurodegenerative diseases and psychiatric disorders. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Concussion, Stress Disorders, Post-Traumatic
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Feb 2016
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: There are three populations being studied: 1. structural traumatic brain injury 2. non-structural traumatic brain injury 3. non-brain injured (bodily or extremity injured)
Who may be able to join
- All patients will be recruited from the Bellevue Hospital Emergency Services (Emergency Department and Trauma Bay) or from among inpatient populations at Bellevue Hospital. They will need to be consentable and able/willing to participate and meet criteria for distribution into one of the three subject populations (structural TBI, non-structural TBI, injured/non-TBI) described here:
- mild to moderate structural traumatic brain injury (TBI) as evidenced by CT scan demonstrating the presence of hemorrhage (subdural, epidural, subarachnoid or intraparenchymal), brain contusion, or skull fracture.
- non-structural TBI(concussion), meaning no signs of structural injury on imaging; however, they complain of usual brain injury symptoms such as headache, dizziness, cognitive impairments, etc., A subject with a traumatically induced physiological disruption of brain function, manifested by >1 of the following:
- Any period of loss of consciousness (LOC).
- Any loss of memory for events immediately before or after the accident.
- Any alteration in mental state at the time of accident (i.e. feeling dazed, disoriented, or confused).
Show all 11Show fewer
- Focal neurological deficit(s) that may or may not be transient, but where the severity of the injury does not exceed the following:
- Loss of consciousness of approximately 30 minutes or less
- After 30 minutes, an initial Glasgow Coma Scale (GCS) of 13-15
- Posttraumatic amnesia (PTA) not greater than 24 hours.
- Non-brain injured subjects that have suffered some type of injury such as to the extremities or other parts of the body. The subjects will have sustained a blunt or penetrating trauma such as, to the corpus or extremities (i.e. car accident, falling).
Who cannot join
- Subjects that receive minor penetrating trauma insufficiently traumatizing to result in sufficient sequelae will be excluded.
- Subjects suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability will also be excluded.
- Particularly for the purposes of eye tracking all subjects that are blind (no light perception), are missing eyes, do not open eyes will be excluded from the research.
- It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant.
- Any physical or mental injury or baseline disability rendering task completion difficult will be excluded, also inability to participate in longtitudinal care, or obvious intoxication or blood alcohol level greater than 0.2.
- Pregnant individuals and prisoners will also be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Concussion and PTSD in Structurally Brain Injured, Non-Structurally Brain Injured and Non-Brain Injured Trauma Victims in Bellevue HHC
Mild brain injury or concussion affects about four million Americans each year. Some people recover completely while others, especially those with multiple concussions, develop chronic headaches, neurodegenerative diseases and psychiatric disorders. One of the reasons that concussion is difficult to treat is that it is difficult to detect. Radiographic studies such as CT (computed tomography scan) are by definition unrevealing of structural injury in concussed patients. Some MRI (magnetic resonance imaging) sequences may be useful adjuncts in the diagnosis of concussion but even these are not consistently present in all patients with symptoms. Clinical tests for concussion often require baseline studies, and thus are generally reserved for athletes and others at highest risk for concussion.
The investigators have developed a novel eye movement tracking algorithm performed while subjects watch television or a music video that determines whether the eyes are moving together (conjugate) or are subtly not together (disconjugate). The investigators preliminary data shows that people with lesions in their brain or recovering from brain injury have disconjugate gaze that is not detectable by ophthalmologic examination but is detected by our algorithm.
Read the detailed description
The purpose of this study is to test the validity of this eye tracking algorithm for detecting structural (visible on CT scan) and non-structural (concussive) brain injury. The study will recruit brain injured subjects and non-brain injured controls from the Bellevue Hospital Emergency Department and neurosurgery services for eye-tracking as well as studies that assess the extent of brain injury. The investigators will determine if disconjugate gaze on eye tracking is significantly associated with abnormal functional, neuro-cognitive, and psychiatric outcomes.
The investigators hypothesize that individuals who demonstrate sustained disconjugate gaze on the eye tracking task from the time of injury to 1 month will have elevated functional impairment in multiple domains of life (work, interpersonal relationships), will be poor performers on neuro-cognitive tasks (working memory, executive functioning, verbal memory, impulsivity), and will be significantly more symptomatic of posttraumatic stress disorder (PTSD) and depression than those who demonstrate conjugate eye tracking in the normal range at one month. Achievement of the investigators aims will provide the first evidence that eye tracking is a valid physiologic outcome measure for brain injury.
- Conditions
- Concussion, Stress Disorders, Post-Traumatic
- Keywords
- brain injury, concussion, post traumatic stress
- Medical subject headings
- Brain Concussion, Stress Disorders, Post-Traumatic, Brain Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Concussive Syndrome (PCS) and/or Posttraumatic Stress Disorder (PTSD) Development
The current effort in the trauma field is focusing on cognitive, behavioral, neural, genetic, and emotional models of traumatic stress. The unique aspect of this approach is that it integrates and examines these perspectives side by side to determine their additive value in predicting outcomes rather than taking a myopic approach.
Possible predictors of post-traumatic stress or concussive symptoms will be done by the completion of neuropsychiatric and cognitive testing and self-report tasks that can be completed over the Internet using HIPAA compliant online survey tools. This testing will assess brain or mental function including memory, intelligence, ability to concentrate, and "mental quickness". Eye tracking, which consist of watching videos that would be shown on public television or are rated PG (videos by popular artists and sports highlight videos), and the SCAT3/CHILD SCAT3 questionnaire with balance task.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMay 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: PI has left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uzma Samadani, MD, PhD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119533
- Sponsor's protocol ID
- 13-00465
- Acronym
- CAPIT
- Status last verified
- Nov 2017
- First submitted
- 8 Jul 2013
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Concussion and PTSD in Structurally Brain Injured, Non-Structurally Brain Injured and Non-Brain Injured Trauma Victims in Bellevue HHC
- ClinicalTrials.gov ID
- NCT02119533
- Acronym / sponsor ID
- CAPIT / 13-00465
- Conditions
- Concussion, Stress Disorders, Post-Traumatic
- Keywords
- brain injury, concussion, post traumatic stress
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI has left the institution.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Apr 2014 (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 brain injury or concussion affects about four million Americans each year. Some people recover completely while others, especially those with multiple concussions, develop chronic headaches, neurodegenerative diseases and psychiatric disorders. One of the reasons that concussion is difficult to treat is that it is difficult to detect. Radiographic studies such as CT (computed tomography scan) are by definition unrevealing of structural injury in concussed patients. Some MRI (magnetic resonance imaging) sequences may be useful adjuncts in the diagnosis of concussion but even these are not consistently present in all patients with symptoms. Clinical tests for concussion often require baseline studies, and thus are generally reserved for athletes and others at highest risk for concussion.
The investigators have developed a novel eye movement tracking algorithm performed while subjects watch television or a music video that determines whether the eyes are moving together (conjugate) or are subtly not together (disconjugate). The investigators preliminary data shows that people with lesions in their brain or recovering from brain injury have disconjugate gaze that is not detectable by ophthalmologic examination but is detected by our algorithm.
Detailed description
The purpose of this study is to test the validity of this eye tracking algorithm for detecting structural (visible on CT scan) and non-structural (concussive) brain injury. The study will recruit brain injured subjects and non-brain injured controls from the Bellevue Hospital Emergency Department and neurosurgery services for eye-tracking as well as studies that assess the extent of brain injury. The investigators will determine if disconjugate gaze on eye tracking is significantly associated with abnormal functional, neuro-cognitive, and psychiatric outcomes.
The investigators hypothesize that individuals who demonstrate sustained disconjugate gaze on the eye tracking task from the time of injury to 1 month will have elevated functional impairment in multiple domains of life (work, interpersonal relationships), will be poor performers on neuro-cognitive tasks (working memory, executive functioning, verbal memory, impulsivity), and will be significantly more symptomatic of posttraumatic stress disorder (PTSD) and depression than those who demonstrate conjugate eye tracking in the normal range at one month. Achievement of the investigators aims will provide the first evidence that eye tracking is a valid physiologic outcome measure for brain injury.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- There are three populations being studied: 1. structural traumatic brain injury 2. non-structural traumatic brain injury 3. non-brain injured (bodily or extremity injured)
Key inclusion criteria (11 listed)
- All patients will be recruited from the Bellevue Hospital Emergency Services (Emergency Department and Trauma Bay) or from among inpatient populations at Bellevue Hospital. They will need to be consentable and able/willing to participate and meet criteria for distribution into one of the three subject populations (structural TBI, non-structural TBI, injured/non-TBI) described here:
- Any period of loss of consciousness (LOC).
- Any loss of memory for events immediately before or after the accident.
- Any alteration in mental state at the time of accident (i.e. feeling dazed, disoriented, or confused).
- Focal neurological deficit(s) that may or may not be transient, but where the severity of the injury does not exceed the following:
Key exclusion criteria (6 listed)
- Subjects that receive minor penetrating trauma insufficiently traumatizing to result in sufficient sequelae will be excluded.
- Subjects suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability will also be excluded.
- Particularly for the purposes of eye tracking all subjects that are blind (no light perception), are missing eyes, do not open eyes will be excluded from the research.
- It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant.
- Any physical or mental injury or baseline disability rendering task completion difficult will be excluded, also inability to participate in longtitudinal care, or obvious intoxication or blood alcohol level greater than 0.2.
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
Post-Concussive Syndrome (PCS) and/or Posttraumatic Stress Disorder (PTSD) Development
Time frame: up to 12 months
The current effort in the trauma field is focusing on cognitive, behavioral, neural, genetic, and emotional models of traumatic stress. The unique aspect of this approach is that it integrates and examines these perspectives side by side to determine their additive value in predicting outcomes rather than taking a myopic approach. Possible predictors of post-traumatic stress or concussive symptoms will be done by the completion of neuropsychiatric and cognitive testing and self-report tasks that can be completed over the Internet using HIPAA compliant online survey tools. This testing will assess brain or mental function including memory, intelligence, ability to concentrate, and "mental quickness". Eye tracking, which consist of watching videos that would be shown on public television or are rated PG (videos by popular artists and sports highlight videos), and the SCAT3/CHILD SCAT3 questionnaire with balance task.
Results and safety
The study was stopped early (reason given: PI has left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
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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
NYU School of Medicine
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 Concussion and Stress Disorders, Post-Traumatic, run by NYU Langone Health 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 11 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Nov 2017. 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 was stopped early (reason given: PI has left the institution.). 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?
Post-Concussive Syndrome (PCS) and/or Posttraumatic Stress Disorder (PTSD) Development (time frame: up to 12 months). 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 7 Nov 2017.