Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT02119533
Brief 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. 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:
NCT02119533
Study Brief:
Protocol Section:
NCT02119533