Concussion Assessment Research Education (CARE) Consortium Longitudinal Clinical Study

Concussion assessment research

Concussion assessment research is important because sports-related concussion (SRC) is a major public health issue and yet clinical management remains among the greatest challenges in sports medicine.

The National Collegiate Athletic Association (NCAA) and Department of Defense (DoD) are collaborating in a multi-tiered, multi-institution/investigator research consortium to address public concerns and existing gaps in the basic and clinical science related to the natural history, evaluation and management, and prevention of SRC. The Longitudinal Clinical Study Core is led by the University of Michigan to assess the natural history of concussion. CHOP serves as a CARE study site in collaboration with the University of Pennsylvania (Penn).

Study Objectives

CHOP's cohort study will enroll and conduct baseline assessments on Penn varsity student-athletes. Those who experience concussion(s) will complete an immediate post-concussion and follow-up assessments.The primary objective of this concussion assessment research is to conduct a prospective, longitudinal, multi-sport, cohort study that delineates the natural history of concussion in both men and women by incorporating a multi-dimensional assessment of standardized clinical measures of post-concussive symptomatology, performance-based testing (cognitive function, postural stability), and psychological health.   

Investigational Plan

Beginning September 2016, approximately 1,000 varsity student-athletes and cheerleaders from Penn Athletics are being invited to participate at the beginning of their sport competitive season. There are currently 30 institutions in the consortium. The larger study plans to enroll and follow an estimated 25,000 male and female student-athletes and service academy cadets over a three-year study period. The study is currently in its 3rd year.

All participants will complete a baseline assessment prior to the official start of their respective competitive sport season. Information will be collected via questionnaires and assessments on the following:

  • Post-concussion assessments and follow-ups will continue to examine symptoms and functions throughout the recovery period.demographics
  • medical history
  • symptoms
  • neurological and neurocognitive functions
  • oculomotor and vestibular functions

All data and records generated during this study will be kept confidential in accordance with Institutional policies and federal HIPAA laws on subject privacy and that the Investigator and other site personnel will not use such data and records for any purpose other than conducting the study.

This data will be aggregated with data from the other performance sites as part of the larger NCAA-DoD Grand Alliance: CARE Consortium project.

Acute Concussion Assessment

What if a participant is diagnosed with a concussion? If a subject is diagnosed with a concussion at any point after enrollment, they will complete post-concussion assessments at scheduled intervals. Immediately, post-concussion participants will complete neurological, postural stability, oculomotor/oculovestibular, and symptom assessments. They will complete daily symptom checks until they are symptom free. They will receive post-concussion follow-ups at set intervals until 6 months post-concussion which will include neurocognitive, neurological, postural stability, oculomotor, vestibular, and symptom assessments.

The concussion assessments being performed at baseline and post-concussion are all standard of care for Penn varsity student athletes. The research element of the study is the collection of the demographic survey information, some additional assessment time points, and the aggregation of the data into a research database as part of the larger CARE Consortium.

Why are oculomotor and vestibular functions important?  Vision disorders and vestibular deficits are common in young concussion patients and can hinder their recovery and getting back to normal school and athletic routines.

Read this blog article about vision disorders that are common after concussion.

Read this article that defines vestibular function and the deficits common after concussion.

Funding: NCAA-U.S. Department of Defense Grand Alliance