Concussion and Post Traumatic Stress in Traumatic Brain Injury (CAPIT)
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.
Stress Disorders, Post-Traumatic
|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|
- 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.
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02119533
|Contact: Uzma Samadani, MD PhD||212.686.7500 ext firstname.lastname@example.org|
|Contact: Marleen Reyes||646 501 email@example.com|
|United States, New York|
|New York, New York, United States, 10016|
|Contact: Marleen Reyes firstname.lastname@example.org|
|Principal Investigator: Uzma Samadani, MD PhD|
|Principal Investigator:||Uzma Samadani, MD, PhD||NYU School of Medicine|