Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury

NCT01287156 | Completed

• 2 other identifiers: 11008411-N-0084
• Study Type: observational
• Target: 1,328
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

Recruitment; TBI; Screening; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Develop a patient recruitment database.

  To facilitate patient recruitment to CNRM sponsored TBI related clinical research at the NIH and participating CNRM sites by developing a patient recruitment database.

  intermittently

Secondary Outcomes (1)

• To evaluate the effectiveness of the recruitment methods utilized in this protocol and determine the most successful outreach approaches and recruitment tools for the recruitment and enrollment of TBI study participants

  Annually, or as needed ad hoc

Study Arms (1)

1

Subjects with diagnosed or suspected TBI or postconcussive syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.@@@

You may qualify if:

• 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

You may not qualify if:

• Are unwilling or unable to cooperate with the study procedures

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• National Institute of Nursing Research (NINR): lead
• Center for Neuroscience and Regenerative Medicine (CNRM): collaborator

Study Sites (4)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Related Publications (3)

• 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.

  PMID: 17122685 BACKGROUND

• 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.

  PMID: 16983222 BACKGROUND

• 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.

  PMID: 16134735 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Lawrence L Latour, Ph.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2011
• First Posted: February 1, 2011
• Study Start: January 10, 2013
• Last Updated: April 20, 2026

Record last verified: 2026-01-06

Locations

US (4)