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Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborators:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
ClinicalTrials.gov Identifier:
NCT01287156
First received: January 29, 2011
Last updated: November 11, 2014
Last verified: August 2014
  Purpose

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.

Condition
Traumatic Brain Injury

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury (TBI)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To facilitate patient recruitment to CNRM sponsored TBI related clinical research at the NIH and participating CNRM sites by developing a patient recruitment database

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 2500
Study Start Date: January 2011
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 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287156

Contacts
Contact: Shristi Joshi (301) 295-4389 shristi.joshi.ctr@usuhs.edu

Locations
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
Uniformed Services University Recruiting
Bethesda, Maryland, United States
University of Maryland at Baltimore/MPRC Recruiting
Catonsville, Maryland, United States, 21228
United States, Virginia
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Investigators
Principal Investigator: Lawrence Latour, Ph.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
ClinicalTrials.gov Identifier: NCT01287156     History of Changes
Other Study ID Numbers: 110084, 11-N-0084
Study First Received: January 29, 2011
Last Updated: November 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Recruitment
TBI
Screening
Traumatic Brain Injury

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014