Concussion and Post Traumatic Stress in Traumatic Brain Injury (CAPIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02119533
First received: July 8, 2013
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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.


Condition
Concussion
Stress Disorders, Post-Traumatic

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Post-Concussive Syndrome (PCS) and/or Posttraumatic Stress Disorder (PTSD) Development [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

    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 questionnaire with balance task.



Estimated Enrollment: 200
Study Start Date: May 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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)
Criteria

Inclusion Criteria:

  • 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).
  • Focal neurological deficit(s) that may or may not be transient, but where the severity of the injury does not exceed the following:

    1. Loss of consciousness of approximately 30 minutes or less
    2. After 30 minutes, an initial Glasgow Coma Scale (GCS) of 13-15
    3. 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).

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02119533

Contacts
Contact: Uzma Samadani, MD PhD 212.686.7500 ext 3665 brainresearch@nyumc.org
Contact: Marleen Reyes 646 501 6846 brainresearch@nyumc.org

Locations
United States, New York
Bellevue HHC Recruiting
New York, New York, United States, 10016
Contact: Marleen Reyes       brainresearch@nyumc.org   
Principal Investigator: Uzma Samadani, MD PhD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Uzma Samadani, MD, PhD NYU School of Medicine
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02119533     History of Changes
Other Study ID Numbers: CAPIT
Study First Received: July 8, 2013
Last Updated: April 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
brain injury
concussion
post traumatic stress

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Brain Injuries
Anxiety Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2014