National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) TBI Model Systems National Database

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 69-03
    Sponsor Protocol Number: 69-03

About this study

The Traumatic Brain Injury Model System (TBIMS) Centers program, begun in 1987, currently consists of 16 centers across the US that are competitively funded for 5 years by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). The TBIMS Centers are situated in centers of excellence for clinical care and innovative research, focused on improving the lives of people with TBI, their families, and close others. The primary focus is on moderate to severe TBI, as patients are recruited from inpatient rehabilitation to participate in research; however, many TBIMS investigators are also interested in mild TBI, or concussion. The National Database (NDB), managed by the TBIMS National Data and Statistical Center, is at the core of the TBIMS Centers program. More than 15,000 individuals are currently enrolled in the NDB. Each TBIMS center collects and enters into the NDB an identical data set on each individual, which captures: 1) Emergency and acute care information such as CT scan findings and depth/ duration of loss or alteration of consciousness; 2) Status and progress during inpatient rehabilitation; 3) Pre-injury social and demographic data; 4) Findings from a battery of measures assessing functional, social, emotional, and medical outcomes at 1, 2, 5, 10, 15 years after the TBI and every five years thereafter. The TBIMS is unique in the scope of its longitudinal data on the outcomes of persons with complex mild/moderate/ severe TBI. Recent research has confirmed that the TBIMS NDB is representative of persons receiving inpatient rehabilitation for TBI in the US. In addition to the enrollment and data capture for the NDB, NIDILRR funding supports the following types of TBI research within TBIMS Centers: 1) Data mining studies, which examine relationships among existing data elements in the NDB; 2) Local research projects, which are site-specific studies proposed for each 5-year grant cycle; 3) Module research projects, which are time-limited, multi-center studies designed to capitalize on the TBIMS infrastructure to address focused research questions that cannot feasibly be answered by a single center. In each 5-year cycle, centers propose and participate in modular studies of interest to them. Module projects have produced new knowledge on (e.g.) the natural history and typology of headache after TBI, the prevalence and outcomes of treatments for deep venous thrombosis, and the feasibility and utility of assessing cognitive function via telephone. The TBIMS centers work in collaboration with the separately-funded Model Systems Knowledge Translation Center to provide scientific results and information for dissemination to stakeholders, including persons with TBI and their families, researchers, clinicians, and policymakers.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

All persons who:

  1. Fit the case definition
  2. Meet at least one of the following criteria for moderate to severe TBI
    1. PTA > 24 hours
    2. Trauma related intracranial neuroimaging abnormalities
    3. LOC exceeding 30 minutes (unless due to sedation or intoxication)
    4. Glasgow Coma Scale (GCS) in the ER of less than 13 (unless due to intubation, sedation, or intoxication)
  3. Are age 16 or older at time of injury
  4. Present to the TBIMS acute care hospital within 72 hours of injury
  5. Receive both acute hospital and comprehensive rehabilitation care in a designated TBIMS program. ‘Program’ is defined by each Center and approved by the Center’s project officer.
  6. Understand and provide informed consent to participate or if unable, family or legal guardian understands and provides proxy consent

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Allen Brown, M.D.

Open for enrollment

Contact information:

Anne Moessner R.N.

(507)255-5109

Moessner.Anne@mayo.edu

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CLS-20312410

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