Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury

Objective

This screening and registry protocol is designed to facilitate subject recruitment for the
Center for Neuroscience and Regenerative Medicine (CNRM) sponsored clinical research studies
on traumatic brain injury (TBI) at the National Institutes of Health (NIH) and participating
CNRM sites. This protocol will serve as a first step for evaluating subjects for possible
inclusion in CNRM sponsored natural history, observational, or interventional protocols.
Other approved CNRM protocols may continue to recruit subjects directly into their respective
studies, and may refer subjects to this study.

The objective of this protocol is to develop a subject recruitment database that will house
preliminary data on research subjects who are interested in and potentially eligible for
current and future CNRM sponsored protocols. The effectiveness of the recruitment methods
utilized in this protocol will be evaluated to determine the most successful outreach
approaches and recruitment tools for the enrollment of TBI or post concussive study subjects.

Study Population

This protocol will enroll 2500 male and female adult subjects with signs/symptoms or
diagnosis of TBI or post-concussive syndrome, from participating sites, other CNRM sponsored
protocols and within the community using various methods of outreach and advertisement.

Design

This study involves an initial study visit conducted in one of two ways: at the NIH Clinical
Center,or at the participating site. Subjects enrolled acutely and/or at a participating site
may also be provided the option to complete an additional visit at the NIH CC after their
initial visit. Based on the information obtained during the initial study visit, the subject
will be referred to appropriate CNRM protocols for further protocol-specific screening prior
to enrollment, or informed that s/he is not eligible for any other actively enrolling CNRM
studies at this time. Study procedures may include: physical exam, medical history, nursing
evaluation, questionnaires completed by interview, blood and urine sample collection, and
magnetic resonance imaging (MRI).

Follow-up visits will be conducted by telephone at regular intervals for a year, and then ad
hoc at potential referral eligibility to update contact information and collect outcome data.
No treatment is offered under this protocol.

Outcome Measures

The outcome measures include accrual of subjects, retention of enrolled subjects and loss to
follow-up, and referral number and rate of enrolled subjects to other CNRM studies. In
addition, we will evaluate the frequency and certainty of injury classification (possible,
probable, or definite TBI).

- INCLUSION CRITERIA:

To be included, participants must meet all of the following:

- Age greater than or equal to 18 years of age

- Report having symptoms or diagnosis of concussion, TBI, post concussional syndrome, or
post concussional disorder.

- Are able to provide informed consent or, have a legally authorized representative
(LAR) provide consent.

- Are willing to have their contact information and data shared and stored by the CNRM
for referral to current and future CNRM studies

EXCLUSION CRITERIA:

-Are unwilling or unable to cooperate with the study procedures