Background: - The Center for Neuroscience and Regenerative Medicine is working to improve physicians' understanding of brain injury. More information is needed on traumatic brain injury (TBI), especially how well a person recovers from TBI and how the brain changes over time in people with TBI. To conduct this research, the center is sponsoring a number of research studies on TBI and is interested in evaluating individuals with TBI or post-concussive syndrome to determine if they might be eligible for future studies. Objectives: - To develop a pool of individuals with traumatic brain injury and post-concussive syndrome for future research studies. Eligibility: - Individuals at least 18 years of age who have symptoms of or have been diagnosed with traumatic brain injury or post-concussive syndrome and are willing to participate in future studies. Design: - Participants will be screened with an initial telephone interview, and will be asked to come to the National Institutes of Health for an in-person screening visit. - At the screening visit, participants will provide a medical history, have a physical examination and complete a study questionnaire on their TBI and its symptoms, including how the injury occurred, when it occurred, and any previous brain-related injuries. - Subjects may also return for a second visit at the NIH CC if eligible. - Each visit may involve blood samples, an MRI scan, and a series of tests to evaluate brain function. - Participants will also provide contact information to enable researchers to contact them for future studies....

Population

Enrollment in this protocol will occur at a participating site MedStar Washington Hospital Center (WHC) or Johns Hopkins Suburban Hospital (Suburban), or at the NIH Clinical Center (NIH CC). Applicable study procedures will depend on the visit site, diagnostic certainty, and logistic considerations such as distance from NIH and feasibility of transport. All subjects will undergo a study visit at a participating enrollment site and/or the NIH Clinical Center. Subjects enrolled acutely at the NIH CC may undergo an additional study visit at the NIH. Phone follow-up will occur at 6-months, 1 year from initial consent. Additional subject follow-up contact will be made should @@@a subject become eligible for referral to another eligible protocol.@@@

Brief Title

Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury

Official Title

Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury (TBI)

Brief Summary

Background: <br /> <br /> - The Center for Neuroscience and Regenerative Medicine is working to improve physicians' <br /> understanding of brain injury. More information is needed on traumatic brain injury (TBI), <br /> especially how well a person recovers from TBI and how the brain changes over time in people <br /> with TBI. To conduct this research, the center is sponsoring a number of research studies on <br /> TBI and is interested in evaluating individuals with TBI or post-concussive syndrome to <br /> determine if they might be eligible for future studies. <br /> <br /> Objectives: <br /> <br /> - To develop a pool of individuals with traumatic brain injury and post-concussive syndrome <br /> for future research studies. <br /> <br /> Eligibility: <br /> <br /> - Individuals at least 18 years of age who have symptoms of or have been diagnosed with <br /> traumatic brain injury or post-concussive syndrome and are willing to participate in future <br /> studies. <br /> <br /> Design: <br /> <br /> - Participants will be screened with an initial telephone interview, and will be asked to <br /> come to the National Institutes of Health for an in-person screening visit. <br /> <br /> - At the screening visit, participants will provide a medical history, have a physical <br /> examination and complete a study questionnaire on their TBI and its symptoms, including <br /> how the injury occurred, when it occurred, and any previous brain-related injuries. <br /> <br /> - Subjects may also return for a second visit at the NIH CC if eligible. <br /> <br /> - Each visit may involve blood samples, an MRI scan, and a series of tests to evaluate <br /> brain function. <br /> <br /> - Participants will also provide contact information to enable researchers to contact them <br /> for future studies....

Detailed Description

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).

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.