Traumatic Brain InjuryNCT01287156
Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by National Institute of Nursing Research (NINR) at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 1,328 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Jan 2013to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.@@@
Who may be able to join
- 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
Who cannot join
- -Are unwilling or unable to cooperate with the study procedures
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Suburban Hospital
Bethesda, Maryland, 20814
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury (TBI)
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.
Read more
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....
Read the 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).
- Conditions
- Traumatic Brain Injury
- Keywords
- Recruitment, TBI, Screening, Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects with diagnosed or suspected TBI or postconcussive syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Annually, or as needed ad hoc
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study start10 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,328 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Center for Neuroscience and Regenerative Medicine (CNRM)
- Responsible party
- Sponsor
- Investigators
- Lawrence L Latour, Ph.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287156
- Sponsor's protocol ID
- 110084
- Other IDs
- 11-N-0084
- Status last verified
- 6 Jan 2026
- First submitted
- 29 Jan 2011
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17122685Langlois 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.
PubMed 16983222Kraus 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.
PubMed 16134735
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury (TBI)
- ClinicalTrials.gov ID
- NCT01287156
- Acronym / sponsor ID
- 110084
- Conditions
- Traumatic Brain Injury
- Keywords
- Recruitment, TBI, Screening, Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,328 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Center for Neuroscience and Regenerative Medicine (CNRM)
- Study start
- 10 Jan 2013 (actual)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects with diagnosed or suspected TBI or postconcussive syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.@@@
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -Are unwilling or unable to cooperate with the study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Develop a patient recruitment database.
Time frame: intermittently
To facilitate patient recruitment to CNRM sponsored TBI related clinical research at the NIH and participating CNRM sites by developing a patient recruitment database.
1 secondary outcome
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
Time frame: Annually, or as needed ad hoc
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 17122685Rutland-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.
- Background: PubMed 16983222Langlois 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.
- Background: PubMed 16134735Kraus 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence L Latour, Ph.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by National Institute of Nursing Research (NINR) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a patient recruitment database. (time frame: intermittently). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01287156, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.