Here at HSS we are working on several research studies to help better understand, diagnose and treat concussions.
Advanced MRI Applications for Mild Traumatic Brain Injury (phase 2)
IRB # 15038
This feasibility study, sponsored by General Electric Healthcare (GEHC), is being conducted to determine potential associations between a broad range of clinical neurological assessments, as well as MR images and data in patients with and without mild Traumatic Brain Injury (mTBI).
Comprehensive characterization of mTBI pathophysiology using modern technologies can provide precise information on brain injury magnitude and location. Unlike computed tomography (CT) systems, which are less costly but have limited usefulness in mTBI due to relatively low sensitivity to diffuse brain damage, magnetic resonance imaging (MRI) can detect characteristics of regional brain abnormalities necessary for diagnostic and prognostic decision-making. Significant scientific advancements, however, will be required before MRI can provide extensive and reliable data required to diagnose and predict progression of mTBI. This study may help us to design better MRI examinations for future patients with head injury.
This study involves new investigational software sequences that are being developed to improve the way imaging is used to examine head injury. Patients who enroll will receive prompt medical care and an MRI examination. Subjects’ participation involves a total of 3 or 4 study visits, depending on when they enroll. The encounter windows are as follows: E1 must occur within 72 hours, E2 must occur within 5-9 days, E3 must occur within 12 to 16 days, E4 must occur within 83 to 97 days.
Each visit includes a meeting with Dr. Shetty that is approximately 80 minutes and a subsequent MRI that lasts approximately 60 minutes. Participants are paid $100 USD per visit and are reimbursed for reasonable travel expenses with the submission of receipts.
This study attempts to determine factors which influence recovery from a concussion and to investigate the correlation between duration and quality of prescribed rest and recovery time. Concussion is a complex pathophysiologic process induced by traumatic biomechanical forces which then cause a disturbance of brain function. The prescribed treatment for a concussion is physical and cognitive rest. Both physicians and patients struggle with defining the prescription of "rest" and also understanding the consequences of compliance with this prescription.
Any patient between the ages 10 and 50 years that schedules an appointment for a concussion is asked to complete a questionnaire regarding their activity during their recovery period. This study does not have a sponsor and participants are not paid for completing the questionnaire.
Detection of Biomarkers of Mild, Moderate and Severe Traumatic Brain Injury
Currently, no definitive blood biomarker exists to determine diagnosis or prognosis of a concussion. Because the diagnosis of a concussion currently relies on a subjective symptom assessment, many neurologists and companies are searching for a blood biomarker that may be used as an objective diagnostic tool. Dr. Shetty is heavily involved in this search. She is currently working as the principal investigator for multiple blood biomarker studies, including one sponsored by Chembio Diagnostics and Perseus Proteomics. This study may have tremendous clinical implications, as a definitive blood test used for diagnosis or to determine recovery could greatly improve concussion care.
This study takes place at one time point within 15 days of the head injury. One vial of blood is taken in order to perform the blood biomarker tests. Neurological assessments are also administered to determine a patient’s cognition, balance, and memory. Participants are paid $100 USD for this visit and are reimbursed for reasonable travel expenses with the submission of receipts.
Non-concussion patients interested in participating as study controls are incredibly helpful to the advancement of our studies.
Control patients can come in for their baseline visit at any time. There are four visits, but only the first and final are required. E2 would take place 5-9 days after baseline. E3 visit would be 12-16 days after baseline. The final visit would be 83-97 days after baseline (E4).