Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury
NCT ID: NCT01287156
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1328 participants
OBSERVATIONAL
2013-01-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
\- 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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Subjects with diagnosed or suspected TBI or postconcussive syndrome
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Center for Neuroscience and Regenerative Medicine (CNRM)
FED
National Institute of Nursing Research (NINR)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lawrence L Latour, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington Hospital Center
Washington D.C., District of Columbia, United States
Suburban Hospital
Bethesda, Maryland, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rutland-Brown W, Langlois JA, Thomas KE, Xi YL. Incidence of traumatic brain injury in the United States, 2003. J Head Trauma Rehabil. 2006 Nov-Dec;21(6):544-8. doi: 10.1097/00001199-200611000-00009.
Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.
Kraus MF, Smith GS, Butters M, Donnell AJ, Dixon E, Yilong C, Marion D. Effects of the dopaminergic agent and NMDA receptor antagonist amantadine on cognitive function, cerebral glucose metabolism and D2 receptor availability in chronic traumatic brain injury: a study using positron emission tomography (PET). Brain Inj. 2005 Jul;19(7):471-9. doi: 10.1080/02699050400025059.
Related Links
Access external resources that provide additional context or updates about the study.
NIH Clinical Center Detailed Web Page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11-N-0084
Identifier Type: -
Identifier Source: secondary_id
110084
Identifier Type: -
Identifier Source: org_study_id