Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury

This study is currently recruiting participants.
Verified September 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborators:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01287156
First received: January 29, 2011
Last updated: March 14, 2014
Last verified: September 2013

January 29, 2011
March 14, 2014
January 2011
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To facilitate patient recruitment to CNRM sponsored TBI related clinical research at the NIH and participating CNRM sites by developing a patient recruitment database
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Complete list of historical versions of study NCT01287156 on ClinicalTrials.gov Archive Site
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
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Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury
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.

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 an electrocardiogram, provide blood samples, 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.
  • Participants will also provide contact information to enable researchers to contact them for future studies.

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 three ways: 1) at the NIH Clinical Center, 2) at the participating site, or 3) by telephone. 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 6-month intervals 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).

Observational
Time Perspective: Prospective
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Traumatic Brain Injury
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2500
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  • 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, if enrolled in-person at NIH CC or enrolling site, 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 unable to provide their own informed consent for the study, if enrolled by telephone
  • Are unwilling or unable to cooperate with the study procedures
Both
18 Years and older
No
Contact: Shristi Joshi (301) 295-4389 shristi.joshi.ctr@usuhs.edu
United States
 
NCT01287156
110084, 11-N-0084
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National Institute of Nursing Research (NINR)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Center for Neuroscience and Regenerative Medicine (CNRM)
Principal Investigator: Lawrence Latour, Ph.D. National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health Clinical Center (CC)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP